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48–284 PDF 2010

S. HRG. 111–252 

AGRICULTURE, RURAL DEVELOPMENT, FOOD AND 

DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2010 

HEARINGS 

BEFORE A

SUBCOMMITTEE OF THE 

COMMITTEE ON APPROPRIATIONS 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

ON

H.R. 2997/S. 1406 

AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES PROGRAMS FOR THE FISCAL YEAR ENDING SEPTEMBER 30, 2010, 

AND FOR OTHER PURPOSES 

Department of Agriculture 

Department of Health and Human Services: Food and Drug 

Administration 

Nondepartmental witnesses 

Printed for the use of the Committee on Appropriations 

( 

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html 
(II) 

COMMITTEE ON APPROPRIATIONS 

DANIEL K. INOUYE, Hawaii, Chairman 

ROBERT C. BYRD, West Virginia 

PATRICK J. LEAHY, Vermont 

TOM HARKIN, Iowa 

BARBARA A. MIKULSKI, Maryland 

HERB KOHL, Wisconsin 

PATTY MURRAY, Washington 

BYRON L. DORGAN, North Dakota 

DIANNE FEINSTEIN, California 

RICHARD J. DURBIN, Illinois 

TIM JOHNSON, South Dakota 

MARY L. LANDRIEU, Louisiana 

JACK REED, Rhode Island 

FRANK R. LAUTENBERG, New Jersey 

BEN NELSON, Nebraska 

MARK PRYOR, Arkansas 

JON TESTER, Montana 

ARLEN SPECTER, Pennsylvania 

THAD COCHRAN, Mississippi 

CHRISTOPHER S. BOND, Missouri 

MITCH MCCONNELL, Kentucky 

RICHARD C. SHELBY, Alabama 

JUDD GREGG, New Hampshire 

ROBERT F. BENNETT, Utah 

KAY BAILEY HUTCHISON, Texas 

SAM BROWNBACK, Kansas 

LAMAR ALEXANDER, Tennessee 

SUSAN COLLINS, Maine 

GEORGE V. VOINOVICH, Ohio 

LISA MURKOWSKI, Alaska 

CHARLES J. HOUY, Staff Director 

BRUCE EVANS, Minority Staff Director 

SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG

ADMINISTRATION, AND RELATED AGENCIES

HERB KOHL, Wisconsin, Chairman 

TOM HARKIN, Iowa 

BYRON L. DORGAN, North Dakota 

DIANNE FEINSTEIN, California 

RICHARD J. DURBIN, Illinois 

TIM JOHNSON, South Dakota 

BEN NELSON, Nebraska 

JACK REED, Rhode Island 

MARK PRYOR, Arkansas 

ARLEN SPECTER, Pennsylvania 

DANIEL K. INOUYE, Hawaii 

(ex officio) 

SAM BROWNBACK, Kansas 

ROBERT F. BENNETT, Utah 

THAD COCHRAN, Mississippi 

CHRISTOPHER S. BOND, Missouri 

MITCH MCCONNELL, Kentucky 

SUSAN COLLINS, Maine 

Professional Staff 

GALEN FOUNTAIN

JESSICA ARDEN FREDERICK

DIANNE NELLOR

FITZHUGH ELDER IV (Minority) 

STACY MCBRIDE (Minority) 

Administrative Support 

MOLLY BARACKMAN
(III) 

C O N T E N T S 

THURSDAY, MAY 21, 2009 

Page 

Department of Health and Human Services: Food and Drug Administration ... 1 

THURSDAY, JUNE 4, 2009 

Department of Agriculture: Office of the Secretary .............................................. 47 

Nondepartmental Witnesses ................................................................................... 113 

(1) 

AGRICULTURE, RURAL DEVELOPMENT, FOOD 

AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR 

FISCAL YEAR 2010 

THURSDAY, MAY 21, 2009 

U.S. SENATE, 

SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, 

Washington, DC. 

The subcommittee met at 2:14 p.m., in room SD–192, Dirksen 

Senate Office Building, Hon. Herb Kohl (chairman) presiding. 

Present: Senators Kohl, Pryor, Brownback, and Bennett. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION

STATEMENT OF DR. JOSHUA M. SHARFSTEIN, ACTING COMMISSIONER 

ACCOMPANIED BY: 

PATRICK McGAREY, DIRECTOR, OFFICE OF BUDGET FORMULATION AND PRESENTATION, FOOD AND DRUG ADMINISTRATION 

NORRIS COCHRAN, DEPUTY ASSISTANT SECRETARY, OFFICE OF 

BUDGET, DEPARTMENT OF HEALTH AND HUMAN SERVICES 

DR. DAVID ACHESON, ASSOCIATE COMMISSIONER FOR FOODS, 

FOOD AND DRUG ADMINISTRATION 

OPENING STATEMENT OF SENATOR HERB KOHL

Senator KOHL. Good afternoon. We welcome you to hearing. 

Thank you all for coming, and we begin by welcoming Dr. 

Sharfstein back, this time to represent the administration’s fiscal 

year 2010 budget request for the Food and Drug Administration. 

We also are very happy to welcome Mr. Patrick McGarey from 

FDA and Mr. Norris Cochran from DHHS. 

We’re also pleased to note that Dr. Hamburg, the new Commissioner, was confirmed by the Senate on Monday. I met with Dr. 

Hamburg a few weeks ago and I’m certain that she will do a great 

job. 

Dr. Sharfstein, I know that you don’t need to be reminded of the 

importance of the agency that you represent. More than 20 percent 

of all consumer spending is on products regulated by the FDA. It’s 

imperative that this agency is successful in its mission because literally people’s lives depend on it. 

Even though you haven’t been on the job that long, you don’t 

need to be reminded of the increased workload FDA has faced over 

the past decade or that the budget increases historically have not 
2 

kept pace with this workload. The effects of this have been widespread. 

For example, you’ve inherited an agency where staff morale is 

low. There have been widely publicized drug safety and food safety 

problems resulting in low consumer confidence. Deserved or not, 

the FDA has earned a reputation for reacting to problems instead 

of preventing them, and there remains a perception the FDA is 

much too cozy with the industries that it regulates. 

However, we have hopefully turned the corner, at least when it 

comes to the FDA’s funding. The numbers speak for themselves. As 

chairman I’ve pushed to help FDA’s budget keep pace with the 

challenges. 

Of all the items funded by this subcommittee, FDA’s increases 

are among the very highest. We recognize that the agency cannot 

continue to receive additional responsibilities without the proper 

resources to do the job. 

For 2010, I’m pleased to see a more realistic budget request from 

this administration. It shows me that you are as serious about fixing the FDA as we on this subcommittee are. I will let you go over 

the details, of course, but here’s the big picture. 

The budget is $2.4 billion. This is an increase of nearly $300 million. These increases include more than $150 million for food safety 

and nearly $100 million for safer drugs and medical products. 

I think everyone in this room can agree that these are substantial numbers. Whether or not they are the right numbers remains 

to be seen. I have said before and will continue to say that the answers to all of FDA’s problems do not lie simply in more money. 

We do not write blank checks. This money has to be spent intelligently and we must continue to question each step taken. No one 

expects a complete overhaul of the FDA to be done overnight, but 

we do expect results and, of course, we expect results soon. 

Dr. Sharfstein, you are new. Dr. Hamburg is new. This entire administration is new. You’ve inherited an FDA with lots of problems 

but also ample opportunity and full support for your efforts from 

this subcommittee. 

I’m committed to working with you during your tenure and I look 

forward to hearing, along with everyone else, your statement today, 

but before we get to that, we will be pleased to hear from Mr. 

Brownback. 

STATEMENT OF SENATOR SAM BROWNBACK

Senator BROWNBACK. Thank you, Mr. Chairman. Welcome, panel. 

Appreciate you being here. 

I think the chairman’s outlined some of the concerns that I have, 

as well. That is, you’ve had a substantial increase in the budget 

portfolio, and I want to know what you’ve done with it. 

I was looking here at the figures. The increase in FDA’s appropriation is 39 percent since fiscal year 2006, and if the budget is 

enacted into law as requested, this year FDA will have grown by 

over 59 percent in 4 years in your budget. Well, we sure want to 

know what you’re doing with that, when we’ll see the results of 

that. So that’s going to be at the core of what I’m interested in seeing that you do. 
3 

Another piece that I think is important that we’ve done in differing degrees in the past is making drug availability and new drug 

development for patients who are terminally ill who don’t have 

other options. 

Dianne Feinstein and I co-chair the Cancer Caucus in the Senate 

and, as many people, I have had cancer and I look at some of these 

things and the length of time that we’re putting in studies on items 

for patients that don’t have other options and it doesn’t seem like 

we’re getting the accessibility to a number of these when you’re a 

terminally ill patient. 

In times past, we’ve worked with certain groups or individuals 

and certainly physicians to try to make earlier stage drugs available for terminally ill patients where they and their physician 

agree to the use of that, and I’m told and the research that I’ve 

seen—some of the early AIDS testing and the successes we had 

were because FDA worked with the community and said, look, we 

don’t know what we’re really dealing with here. We’ve got a Tier 

1 trial that’s going on that looks promising. We’re going to let more 

people try this earlier. That was one of the ways that some of these 

treatments were discovered. 

I would love to see us try to figure a way that you could maintain 

safety but also get access to people who are terminally ill. It just 

seems almost cruel to me that in some cases you have cures that 

are waiting there but people die waiting for that to get approved. 

So I hope you can address some of that, as well. 

It’s a very important agency and I look forward to working with 

you on my tenure on this subcommittee. 

Senator KOHL. Thanks a lot, Senator Brownback. We’re pleased 

and honored to have with us today the former chairman and ranking member of this committee, Senator Bennett. 

STATEMENT OF SENATOR ROBERT F. BENNETT

Senator BENNETT. Thank you very much, Mr. Chairman. I’m always delighted to be able to be here and particularly with respect 

to FDA, which is an agency that you and I worked together so well 

on to try to make sure that they got properly funded and properly 

taken care of. 

Dr. Sharfstein, as you and I have talked, you know that I’m a 

strong supporter of the Critical Path Initiative and it was started 

to address the concern about the rising failure rate of new medical 

products during development and the declining number of approvals and so on, and I think perhaps Senator Brownback was talking 

in that same area when I came in. 

This subcommittee has provided funding for the Critical Path 

Initiative over the past few years and in fiscal year 2008 it was 

$7.5 million, of which $2.5 million was for Critical Path Partnership Grants. Fiscal year 2009 it’s $16 million for Critical Path and 

$4 million for the Partnership Grants. 

Are you—have you been there enough to be able to give us some 

kind of evaluation of the Critical Path and where it’s going and 

how you feel about it and what you might have in mind for it with 

respect to its future? 

Senator KOHL. This is the opening statement. 
4 

Senator BENNETT. Oh, I apologize. That’s my opening statement 

and I’ll ask that question. 

Senator KOHL. We’re going to leave that question for you and 

think about it for awhile. 

Senator BENNETT. Right. 

Senator KOHL. All right. Thank you so much, Senator Bennett, 

and Dr. Sharfstein, we’ll take your statement at this time. 

STATEMENT OF DR. JOSHUA M. SHARFSTEIN

Dr. SHARFSTEIN. Great. Thank you so much. Thank you, Chairman Kohl, Senator Brownback, Senator Bennett. 

I’m very happy to be here. I am Josh Sharfstein. I’m the Principal Deputy Commissioner and the Acting Commissioner but not 

for very long at the U.S. Food and Drug Administration. 

I am pleased to present the President’s fiscal year 2010 budget 

request for FDA. 

For today’s hearing, I’m joined by Patrick McGarey, the Director 

of the Office of Budget Formulation at FDA, and Norris Cochran, 

the Deputy Assistant Secretary for Budget at the Department of 

HHS. 

In my testimony, I’m going to outline the budget request and 

some of the key policy initiatives. I will also just bring you a little 

bit up to date on what’s going on on the flu situation, knowing that 

we had that discussion before but a sort of quick update there. 

Let me start by thanking the subcommittee for exactly what you 

spoke to, the fact that this subcommittee has been extraordinary 

in its support of FDA over the past several years. 

When I arrived at FDA, one of the first things I did is I asked 

each center to provide examples of how it’s using the recent funding increases to promote public health. A key goal for FDA, and 

I’ve only been at FDA for several weeks really, but I think a key 

management goal is for us to be able to connect the investment of 

Federal dollars and taxpayer dollars to actual public health outcomes at the agency, and I got quite a lot back from different parts 

of FDA, and we have a document that we can share with the subcommittee that summarizes some of the things that we were able 

to pull together. 

PUBLIC HEALTH OUTCOMES

But as some examples, FDA, in the blood area, is developing a 

test to identify rare strains of HIV that aren’t picked up on standard HIV testing and then deploy that test around the country. FDA 

is working around the world to train regulators to be able to do 

better device inspections so that the safety of imported medical devices is improved. 

FDA is developing the first hepatitis A test in food so you can 

actually identify hepatitis A in food which would allow for quicker 

identification of a problem, as well as develop rapid tests for food 

safety problems so we’re not waiting for days with, you know, messages out to the public about particular foods. We can really identify the particular contaminant. 

FDA’s developing, with the funding increases, a major national 

network on pet food problems that involves the states and localities 

and veterinarians so that we don’t have a situation like with mel-
5 

amine where so much time goes by and so many animals die if 

there is a problem. 

And FDA is working with its research component at NCTR to improve the safety of pediatric anesthesia by developing new ways to 

measure the use of pediatric anesthesia and the impact on children. 

And then, of course, there’s the flu which we talked about before, 

that the increase is directly related to our preparedness for flu, 

and, I think, right before I testified the last time, FDA had approved a facility that doubled and will eventually triple the domestic manufacturing capacity for the injectable flu vaccine and will 

have an immediate impact on our ability to prepare for the Fall, 

and that would not have been possible without the investments. 

BUDGET REQUEST

So let me take a step back and talk about the budget request overall for this year. It includes $3.2 billion to protect and promote 

the public health through advancing FDA’s work. That includes an 

increase of $510 million for FDA programs which is a 19 percent 

increase over last year. It’s a historic increase and demonstrates 

this administration’s commitment to food safety, medical product 

safety and the health of the American public. It includes $295 million in budget authority and $215 million in 

industry user fees, and this budget organizes these increases into 

two initiatives, in addition to its statutory increases and increases 

for infrastructure. The two initiatives are Safer Food Supply and 

Safer Medical Products. 

The budget also recommends for new user fees, including a user 

fee to facilitate the review of generic drugs, one to enhance FDA’s 

ability to register and inspect feed and food manufacturing and 

processing facilities, one to allow FDA to reinspect facilities that 

fail to meet good manufacturing practice and other safety requirements, and one to allow FDA to collect fees when it issues export 

certifications for food and feed. 

The budget also recommends new authority for FDA to approve 

follow-on biologics for the regulatory pathway that protects patient 

safety and promotes innovation. Finally, the budget includes $5 million for FDA to develop policies to allow Americans to buy safe and effective drugs that are approved in other countries. 

SAFE FOODS

Let me just briefly give some of the highlights of the two initiatives. For Safe Foods, it’s a $259 million increase which includes 

a $164 million in budget authority and $94 million in the user fees. 

This will ultimately increase the number of employees by about 

600, and the funding will go to various efforts. 

One of them is to expand and strengthen the inspection, domestically and foreign, of facilities based on risk. More than 220 of the 

people to be hired will be additional inspectors. 

Another will be to, and in some ways more important, to implement a new strategic framework for an integrated national food 

safety system, so the Federal, State and local systems are not operating kind of just in their own world, so that it’s truly one inte-
6 

grated system, and that’s going to require an upfront investment 

but will have many different benefits because what we’re able to 

do, if we can accomplish this, is leverage the existing investment 

in food safety at the State and local level and increase the quality 

of that work to the point where we can—the Federal Government 

and the States are really working as partners. I’m happy to talk 

more about that. 

FDA is planning to improve its understanding of food 

vulnerabilities and risks which will be the basis of a risk-based system of inspection and to develop standards and regulations that 

build food protection into the complete life cycle from food production to food consumption. 

In addition, in terms of outbreaks, FDA is investing in actions 

to allow it to more quickly identify food outbreaks and trace the 

contamination to its source, to better communicate risks with the 

public and to expand the capacity of laboratories. 

And finally, FDA is making a major investment in information 

technology which will help us provide a much stronger base for all 

of FDA’s efforts in food safety, identify key suppliers into the 

United States and be able to identify risks of the products that are 

coming in, so we don’t feel like we have to do inspections on every 

single product. We can be more strategic about how we’re using resources. 

SAFER MEDICAL PRODUCTS

As far as safer medical products, this effort both relates to the 

manufacture and the use of the products. It’s $166 million. It includes a $120 million in increased budget authority and about $50 

million in generic drug user fees and reinspection user fees. 

It would have FDA hire about 300 more people and expand programs related to medical product safety and included in this are, 

again, increased numbers of inspections, both foreign and domestic. 

The Center for Biologics would hire additional safety experts for 

blood, tissue and vaccine safety teams and develop additional 

screening tests for emerging bloodborne diseases. 

The Center for Devices would implement the safety requirements 

that were called for in the Food and Drug Administration Amendments Act of 2007 which include analyzing adverse event information in children and inspiring more pediatric trials for medical devices. 

It also has a focus on eye medical devices which have been a 

cause of a number of outbreaks recently. 

SAFE DRUGS USE

The Center for Drugs would have funding to support how to best 

use risk evaluation mitigation strategies to minimize drug risks 

and promote safe drug use and would also conduct research on bioequivalent standards for generic forms of new products, such as 

metered dose inhalers, topical drugs and other different kinds of 

products. 
7 

ANIMAL BIOTECH PRODUCTS

The Center for Veterinary Medicine would conduct scientific and 

risk evaluation of animal biotech products, regulate approvals for 

new animal biotech products, and coordinate United States and foreign regulation on animal health issues; and there’d be additional 

research funded through the National Center for Toxicological Research in Arkansas to analyze the consequences of human exposure 

to nano-scale materials, which is very important for this field moving forward. 

And again, there’s a significant investment in information technology, including systems to help facilitate and streamline the approval process. 

LEGISLATIVE INITIATIVES

I’d just briefly mention that there are legislative initiatives that 

are implied by the budget. They include the Generic Drug User Fee 

Program and the Follow-On Biologic Pathway which would have to 

be approved by Congress. 

Let me just very, very briefly give you an update on the one area 

where I think—and this speaks to, I think, Senator Brownback’s 

point, which is that I think you could look at this budget and say 

you’ve got a safer food supply as a goal and a safer medical supply 

as a goal and it’s hard to argue with those things, but what about 

the fact that there are people who are dying who need new treatments which does not exactly fit under—you know, obviously fit 

under the safer part, and I think that’s something that Dr. Hamburg and I take very seriously in this job. 

I think there is some connection insofar if we can develop the 

safety systems that give us more assurance that we have understanding of the products that gives more confidence for earlier approval of products because we can watch what’s happening to them 

closer and not feel that everything rests on the approval decision. 

So I do think there’s a connection, that you can have an approval 

with a plan to monitor it and have confidence in that and then that 

allows you to feel more comfortable about early approvals, but I 

also think that one of the things that’s very important is for FDA 

not to think of itself as purely an agency that just sits back and 

waits for things to come through the door. 

When there are opportunities or challenges to public health, 

there are opportunities for science, we want to make sure that the 

agency is reaching out to the researchers and the companies that 

have particular breakthrough products that are available and facilitating the pathway to approval, talking to them early about 

what would be necessary to demonstrate safety and efficacy, and 

I think one of those—the example of that in the short time that I’ve 

been at FDA relates to the flu. 

H1N1 FLU VIRUS

And we’ve talked a little bit about what the agency has done 

with the flu, but we’re still operating in an incident command management structure where we have dedicated teams and we’re really 

focused on what would it take to best protect the public if the flu 

were to become a major problem, and even though, since we last 
8 

spoke, I think maybe concern for this particular wave of the flu 

may have diminished somewhat, I think there’s still considerable 

concern that when the regular flu season hits, that it could come 

back pretty strongly and that we have to be thinking a step ahead 

and all the teams that I discussed before are still working and I’ll 

just give you a very brief update. 

ANTIVIRAL TEAM

The antiviral team is out knocking on the doors of companies 

that have potential products that could be used to treat severely 

old people with flu, and they’re trying to identify pathways, some 

of which are experimental pathways, to make those products available in case there are a lot of people who are sick. 

SHORTAGE TEAM

The shortage team is already reaching out to the IV suppliers, 

the makers of antibiotics as well as the makers of antivirals, to 

make sure that there’s an adequate supply if there were to be a 

major stress on the medical system this fall. 

VACCINE TEAM

The vaccine team has really been doing a tremendous amount of 

work pulling together the basic protocols with other regulatory 

agencies and the companies to study vaccines. They are also continuing to work with the various strains of the virus so it can be 

produced into a vaccine strain. 

BLOOD TEAM

The blood team is working to monitor the blood supply. There 

have not been any concerns there. 

DIAGNOSTIC TEAM

The diagnostic team is working aggressively with companies and 

the CDC to identify more diagnostics. That test that FDA approved 

in the first like 72 hours of its work has now been distributed to, 

I think, more than 40 States and over a 100 countries and has really made a big difference to the world’s ability to identify this and 

has really reduced the level of, I think, anxiety which is one reason 

why the World Health Organization has not gone all the way up 

to a Level Six pandemic designation. 

CONSUMER PROTECTIVE TEAM

And finally, the consumer protection team has been working and 

has issued more than 30 warning letters, and I’ll just tell you one 

of the most recent ones cited a company that was selling a formula 

that said will kill the virus within a few hours and automatically 

eliminate all your symptoms, and there was another one that said 

scientifically proven only to kill swine flu and bird flu but also 

MRSA, SARS, malaria, anthrax, TB, Bubonic plaque and sexuallytransmitted diseases. So those products are getting some enforcement action and are coming off the Internet. 
9 

PREPARED STATEMENT

So I think that, in conclusion, this is a time of opportunity, of 

incredible challenge for the agency, but also a time of opportunity. 

This budget really does support the agency’s ability to move forward and protect the public, but I think we realize that we’re going 

to have to deliver. We’re the new team at FDA and that we’re 

going to have to come back and demonstrate what these increased 

resources are doing for the health of the American people and look 

forward to working with you to accomplish that. 

[The statement follows:] 

PREPARED STATEMENT OF DR. JOSHUA M. SHARFSTEIN

INTRODUCTION

Chairman Kohl, Ranking Member Brownback and members of the Subcommittee, 

I am Dr. Joshua M. Sharfstein, Principal Deputy Commissioner and Acting Commissioner at the U.S. Food and Drug Administration. I am pleased to present the President’s fiscal year 2010 budget request for the Food and Drug Administration (FDA). 

For today’s hearing, I am joined by Patrick McGarey, FDA’s Director of the Office 

of Budget Formulation and Presentation and Norris Cochran, Deputy Assistant Secretary for Budget at the Department of Health and Human Services. 

In my testimony today, I will outline FDA’s fiscal year 2010 budget request and 

the policy initiatives that we are advancing in our budget. I will also summarize 

recent developments related to the 2009-H1N1 Flu Virus outbreak and describe how 

FDA’s budget for pandemic preparedness allowed us to prepare for and respond to 

the 2009-H1N1 Flu Virus. 

RECENT FUNDING INCREASES

The funding that this subcommittee appropriated to FDA for fiscal year 2008 and 

fiscal year 2009 demonstrates your strong commitment to the public health mission 

of FDA and the health of the American public. Thank you for your support. 

When I arrived at FDA, I asked each FDA center to provide examples of how they 

are using the recent funding increases to promote public health and achieve mission 

priorities. A key goal for FDA is to directly connect the investment of Federal dollars to public health outcomes. 

FDA 2010 BUDGET REQUEST

Overview 

The President’s fiscal year 2010 budget request for FDA includes $3.2 billion to 

protect and promote the public health. The budget contains an increase of $510.6 

million for FDA programs, which is a 19 percent increase compared to the fiscal 

year 2009 budget. This is an historic increase in the FDA budget and demonstrates 

the administration’s commitment to food safety, medical product safety, and the 

health of the American public. 

The fiscal year 2010 increase of $510.6 million includes increases of $295.2 million 

in budget authority and $215.4 million in industry user fees. The FDA budget organizes these increases into initiatives for fiscal year 2010. Our two major initiatives 

are Protecting America’s Food Supply and Safer Medical Products. The budget also 

includes $74.4 million for statutory increases for user fee programs in current law 

and increases for infrastructure to support FDA’s mission. 

The FDA fiscal year 2010 budget recommends four new user fees. The new user 

fees will facilitate the review of generic drugs, enhance FDA’s ability to register and 

inspect food and feed manufacturing and processing facilities, allow FDA to reinspect facilities that fail to meet good manufacturing practices and other safety requirements, and allow FDA to collect fees when it issues export certifications for 

food and feed. 

The fiscal year 2010 budget also recommends new authority for FDA to approve 

generic biologics through a regulatory pathway that protects patient safety and promotes innovation. Finally, the budget also includes $5 million for FDA to develop 

policies to allow Americans to buy safe and effective drugs from other countries. 
10 

DETAILS OF THE FISCAL YEAR 2010 BUDGET

Supply Chain Safety and Security 

The globalization of the manufacturing and supply of foods and medical products 

that FDA regulates and Americans consume poses unique and demanding challenges for FDA. In the complex and rapidly changing environment driven by 

globalization, FDA cannot rely solely on traditional approaches—inspection and 

sampling at the U.S. border—to protect Americans and ensure the safety of foods. 

Rapid globalization requires that FDA implement new approaches and conduct a 

broader range of activities to effectively regulate the supply chain for foods and 

medical products. 

Supply Chain Safety and Security is an overarching principle that applies to both 

food and medical products. Supply Chain Safety and Security holds all segments of 

industry accountable for ensuring that their products meet U.S. safety standards. 

Key components of this initiative include: identifying products and processes at 

high risk for earlier and more comprehensive attention; establishing reasonable and 

effective regulations and other standards; increasing FDA inspections; increasing effective third-party inspections; and collaborating with local, state and international 

partners. 

Protecting America’s Food Supply 

For fiscal year 2010, FDA proposes an increase of $259.3 million for food safety 

activities. This increase includes $164.8 million in budget authority and $94.4 million in three new user fees: Food Inspection and Registration User Fees, Reinspection User Fees related to food facilities, and Export Certification User Fees for food 

and feed products. 

To outline the key investments with the new fiscal year 2010 resources: 

—FDA will hire 678 additional full-time equivalent staff to expand programs and 

activities that protect America’s food supply. 

—FDA will fund the cost of living pay adjustment for FDA professionals that conduct food product program activities. (∂$12.9 million) 

—FDA will increase domestic and foreign risk-based inspections, conduct more audits of controls designed to prevent contamination, establish three additional 

high volume laboratories, and conduct more food safety intervention, sampling 

and surveillance through our Office of Regulatory Affairs. The fiscal year 2010 

budget increase will allow FDA to hire more than 220 additional investigators. 

When fully trained and deployed, the new investigators will enable FDA to conduct the following additional field activities, based on the fiscal year 2010 increases in budget authority and user fees proposed in this initiative: 

—4,000 additional domestic food safety inspections 

—100 additional foreign food and feed inspections 

—20,000 additional import food and feed field exams 

—3,000 additional samples for analysis in FDA laboratories. (∂$101.7 million) 

—FDA will begin to implement a new strategic framework for an integrated national food safety system. Under this framework, FDA will build and expand existing programs and relationships with its regulatory partners: our Federal, 

State, local, tribal and territorial partners. This will allow FDA to increase information sharing and improve the quantity and quality of food safety data that 

FDA receives from its food safety partners. (∂$14.6 million) 

—FDA will work with all stakeholders to better ensure that food protection is 

built into the complete lifecycle, from food production to food consumption. 

(∂$6.0 million) 

—FDA will improve its understanding of food and feed vulnerabilities and risks. 

This will include improving FDA’s ability to use baseline data to measure the 

impact of food safety efforts and to track the status of foodborne illnesses in the 

United States. Achieving a better understanding of vulnerabilities and risks will 

allow FDA to adjust food and feed safety priorities and ensure that food programs achieve the best health benefit for the American public. (∂$4.0 million) 

—FDA will improve its ability to detect signals of contamination and also improve 

its ability to collect and analyze adverse events for food and feed. (∂$9.8 million) 

—FDA will respond more quickly to foodborne outbreaks and will improve its ability to quickly trace contamination to its source. (∂$12.2 million) 

—FDA will improve risk communication during a food safety event so that the 

public can respond promptly to FDA alerts and protect themselves from harm. 

(∂$1.6 million) 

—FDA will increase the capacity of the Food Emergency Response Network by establishing three new laboratories for chemical analysis. (∂$3.3 million) 
11 

—FDA will further develop an integrated genomic data base for Salmonella and 

conduct research to reduce knowledge gaps. (∂$0.8 million) 

—FDA will charge fees to cover the cost of reinspecting FDA-regulated facilities 

that fail to meet good manufacturing practices or other FDA requirements. 

(∂$15.3 million) 

—FDA will charge fees to cover the cost of issuing export certificates for food and 

feed. (∂$4.2 million) 

—FDA will upgrade and integrate information technology systems, including systems that we use to screen, sample, detain and take enforcement actions 

against imported food and feed products that violate FDA safety standards. 

(∂$49.9 million) 

Safer Medical Products 

There are three components of FDA’s Safer Medical Products initiative. Like the 

food safety initiative, the first component relies on the principle of supply chain 

safety and security. The goal is to protect American patients from contamination or 

other manufacturing flaws that could harm patients. The second component will address patient-product interactions that generally do not relate to manufacturing 

flaws. FDA will improve the safety of human drugs, vaccines, blood and other biological products, medical devices, and animal drugs and medicated feed by hiring 

additional safety experts to analyze adverse events associated with these products. 

FDA will also identify safety problems through active surveillance of third party 

healthcare data. The third component focuses on increasing access to affordable generic drugs, granting FDA new authority to approve generic biologics, and allowing 

Americans to buy safe and effective drugs from other countries. 

For fiscal year 2010, FDA proposes an increase of $166.4 million for medical product safety. This increase includes $119.9 million in budget authority and $46.6 million for Generic Drug User Fees and Reinspection User Fees related to medical 

product facilities. 

To outline the key investments with the new fiscal year 2010 resources: 

—FDA will hire 346 additional full time equivalent staff and expand programs 

and activities related to medical product safety. 

—FDA will fund the cost of living pay adjustment for FDA professionals that conduct medical product program activities. (∂$16.7 million) 

—FDA will improve the safety and security of foreign and domestic sources of ingredients, components, and finished products throughout the supply chain—including their eventual use by patients in America—through increased inspections and through activities conducted by the Office of Regulatory Affairs. 

(∂$12.2 million) 

—FDA’s Center for Biological Research and Evaluation (CBER) will hire additional safety experts for its blood, tissue and vaccine safety teams. This will 

strengthen the ability of safety teams to analyze emerging safety threats. CBER 

will modernize blood, tissue and vaccine standards to improve product safety 

and quality. CBER will also provide increased training to support product development and improve product safety. (∂$5.7 million) 

—CBER will develop new screening tests for emerging blood-borne diseases. 

CBER will review vaccine and tissue data to identify safety signals. CBER will 

also develop quality systems for product testing and lot release of biological 

products and will provide additional support for safe development and manufacturing of cell, gene and tissue therapies. (∂$2.3 million) 

—CBER will provide increased technical support to FDA field operations as they 

conduct foreign and domestic inspections of biologic products. (∂$1.3 million) 

—FDA’s Center for Devices and Radiological Heath (CDRH) will implement safety 

requirements related to the FDA Amendments Act (FDAAA). To support 

FDAAA safety activities, CDRH will collect and analyze adverse event information related to medical devices from pediatric hospitals. CDRH will conduct a 

pediatric medical trials workshop to address unmet pediatric device needs. 

CDRH will improve device safety by hiring experts to evaluate software used 

in medical devices. CDRH will hire staff to provide technical support to FDA 

foreign offices and to support FDA field operations as they conduct foreign and 

domestic device manufacturing inspections. (∂$9.5 million) 

—CDRH will develop new safety tests and strengthen postmarket safety reviews 

of ophthalmic medical devices. CDRH will also develop and validate new clinical 

trial methods for imaging devices. (∂$1.7 million) 

—FDA’s Center for Drug Evaluation and Research (CDER) will evaluate how best 

to use Risk Evaluation and Mitigation Strategies to minimize drug risks and 

promote safe drug use. (∂$3.4 million) 
12 

—CDER will also conduct research on bioequivalence standards for generic forms 

of novel products such as metered dose inhalers, topical drugs and complex dosage forms such as liposome products. (∂$2.5 million) 

—CDER will identify and improve enforcement against Internet sites that expose 

consumers to unapproved products and fraud. (∂$2.0 million) 

—FDA’s Center for Veterinary Medicine will conduct scientific and risk evaluation 

of animal biotechnology products, regulate approvals for new animal biotechnology products, and coordinate United States and foreign regulation on 

animal health issues within FDA’s jurisdiction. (∂$0.5 million) 

—FDA’s National Center for Toxicological Research (NCTR) will conduct studies 

to analyze the consequences of human exposure to nanoscale materials. These 

studies will provide the scientific basis for issuing FDA guidance on the safe 

and effective use of nanoscale particles in the products that FDA regulates. 

($1.0 million) 

—NCTR will develop noninvasive techniques to better understand the risks of anesthetic use in children. (∂$0.2 million) 

—FDA will develop policies to allow Americans to buy safe and effective drugs 

from other countries. (∂$5.0 million) 

—FDA will provide greater access to affordable generic drugs and improve the 

productivity of generic drug review through a new user fee program. (∂$36.0 

million) 

—FDA will strengthen the safety of the supply chain through a new user fee program to charge fees to cover the cost of reinspecting FDA-regulated facilities 

that fail to meet good manufacturing practices or other FDA requirements. 

(∂$10.6 million) 

—FDA will modernize and enhance information technology, including systems 

that we rely on to collect, store and analyze the large volume of regulatory, scientific, and risk based information necessary to assure the safety and effectiveness of medical products. (∂$40.1 million) 

Legislative Initiatives for Safe, Affordable Drugs 

The budget request supports greater access to affordable generic drugs, recommends new authority to approve generic biologics, and allows Americans to buy 

safe and effective drugs from other countries. 

In the coming years, patents will expire on more than a dozen blockbuster brandname drugs that account for tens of billions of dollars in prescription spending annually. Generic competition for these drugs will likely be very strong. It is imperative that FDA have the resources to ensure the safety, quality, and therapeutic 

equivalence of generic drugs and allow Americans to benefit from the savings from 

lower cost generic drugs. To meet this priority, FDA’s fiscal year 2010 budget includes $36 million in new user fees to support drug review for new generic products. 

The administration will also accelerate access to affordable generic biologics by 

working with Congress to establish a workable and scientifically sound regulatory 

pathway for approval of generic versions of biologic drugs. 

Current Law User Fees 

FDA user fee programs facilitate enhanced premarket review performance and the 

timely availability of safe and effective medical devices, human and animal drugs, 

biological products, and other FDA-regulated products. The fiscal year 2010 budget 

request includes increases of $74.4 million for existing user fee programs, as authorized by law. The increases expand the available options for treating and curing diseases and other health problems. 

Annual Cost of Living Adjustment 

FDA can only achieve its mission and fulfill its responsibilities if it has sufficient 

resources to pay the scientific, professional, and technical staff required to conduct 

food safety and medical product safety programs. The ongoing experience with the 

outbreak of 2009-H1N1 Flu Virus demonstrates the importance of maintaining pay 

rates to attract and retain top-notch scientists and professionals. The fiscal year 

2010 budget includes $29.5 million for the annual cost of living adjustment for employees in FDA’s food and medical product programs. 

Delivering the FDA mission is a personnel-intensive effort. FDA performs its public health mission through a highly trained professional workforce. Personnel and 

related costs account for 78 percent of FDA’s annual expenditures. To maintain its 

strong science and regulatory capability, FDA must employ, train, develop, and retain highly trained professionals to perform the mission critical work of protecting 

public health. 
13 

Infrastructure to Support FDA Operations 

Like the annual cost of living adjustment, the fiscal year 2010 budget increase 

to pay higher rental costs and other costs for the buildings that FDA occupies will 

allow FDA to perform its public health mission. FDA’s fiscal year 2010 budget contains $14.0 million in budget authority for increased GSA rent and related costs of 

the space that we occupy. 

FDA 2009-H1N1 FLU VIRUS RESPONSE

FDA plays a vital role in preparing for, and responding to, public health challenges such as the one presented by the 2009-H1N1 Flu Virus. FDA is part of the 

team led by the Department of Health and Human Services. 

Since the beginning of the 2009-H1N1 Flu Virus outbreak on Thursday, April 23, 

FDA has worked closely with HHS, our sister HHS agencies, other U.S. government 

agencies, the World Health Organization (WHO), and foreign governments. 

As soon as we became aware of the 2009-H1N1 Flu Virus outbreak, I asked Dr. 

Jesse Goodman, FDA’s Acting Chief Scientist and Deputy Commissioner for Scientific and Medical Programs, to coordinate and lead FDA’s efforts on the 2009- 

H1N1 Flu Virus. Dr. Goodman leads an incident management approach that includes seven substantive teams. The teams are cross-cutting and include staff from 

across FDA as needed. The teams include: Vaccine Team, Antiviral Team, In Vitro 

Diagnostics Team, Personal Protection Team, Blood Team, Shortage Team, and the 

Consumer Protection Team. These teams work with the Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Disease Control and 

Prevention (CDC), other HHS agencies, and national and international partners. 

FDA’s management approach to respond to the outbreak is flexible and likely to 

change over time. It has already changed in response to evolving events. 

Emergency Use Authorizations 

Under the Project Bioshield Act of 2004 (Public Law 108–276), Congress added 

section 564 to the Federal Food, Drug, and Cosmetic Act. Section 564 establishes 

criteria that permit the FDA Commissioner to issue an Emergency Use Authorization, following a determination and declaration of a public health emergency. An 

Emergency Use Authorization allows the use of an unapproved product or of an approved product for an unapproved use. 

On Sunday, April 26, 2009, the Acting HHS Secretary issued a determination that 

a public health emergency exists involving 2009-H1N1 Flu Virus. In the days that 

followed, the Acting Secretary issued declarations under section 564 justifying emergency use of certain antivirals, in vitro diagnostics, and personal respiratory protection devices. 

Based on the Acting Secretary’s actions, and using our authority under the Project 

BioShield Act, on April 27, 2009, FDA issued four Emergency Use Authorizations 

in response to requests from the CDC. Two of these Emergency Use Authorizations 

extend the circumstances in which two FDA-approved drugs, Relenza and Tamiflu, 

can be used to treat and prevent the 2009-H1N1 Flu Virus. A third Emergency Use 

Authorization makes available a test for diagnosing infection with the virus. The 

fourth authorizes the emergency use of certain personal respiratory protection devices, specifically certain disposable respirators certified by CDC’s National Institute 

for Occupational Safety and Health, known as N95 respirators. The emergency use 

authorization for N95 respirators only relates to requirements under the Federal 

Food, Drug and Cosmetic Act, not other requirements such as the standards for 

safety in the workplace administered by the Department of Labor. On May 2, FDA 

issued a fifth Emergency Use Authorization for a first tier test for patient specimens 

with suspected 2009-H1N1 infection. Taken together, these authorizations allow 

CDC and State and local responders to take actions that help meet the medical and 

public health threat. 

All seven of the FDA teams are working to ensure a comprehensive response to 

the 2009- H1N1 Flu Virus. I would like to highlight FDA’s work in two areas, developing a vaccine and protecting consumers. 

Developing an H1N1 Vaccine 

FDA’s Vaccine Team is working to facilitate the availability of a safe and effective 

vaccine to protect the public from the 2009-H1N1 Flu Virus as soon as possible, in 

the event that a vaccine is needed to protect the American public. Members of the 

team are working collaboratively with CDC and other partners in efforts to grow 

and genetically engineer the 2009-H1N1 Flu Virus in the laboratory for possible use 

in a vaccine. FDA is also beginning to prepare reagents that will be essential to help 

manufacturers produce and test the vaccine. 
14 

In a related development, on May 6, FDA announced that it approved a new manufacturing facility to produce influenza virus vaccines. The facility, located in 

Swiftwater, Pennsylvania, is owned and operated by Sanofi Pasteur and will greatly 

increase vaccine production capability. The facility is approved for seasonal influenza vaccine production, and the facility could also be used to produce vaccine 

against the new 2009-H1N1 influenza strain. 

As we work to develop a safe and effective vaccine, FDA is also participating in 

the analysis of whether an H1N1 Flu Virus vaccine should be deployed later this 

year to protect the American public. Decisions about whether to deploy an H1N1 

vaccine will be independent of the decision to produce a vaccine. 

Protecting Consumers 

FDA’s H1N1 Flu Virus consumer protection team works to safeguard consumers 

from fraudulent and potentially dangerous FDA-regulated products or other promotions for products that claim to diagnose, prevent, mitigate, treat, or cure the 

2009-H1N1 Flu Virus. Deceptive products are being sold over the Internet take advantage of the public’s concerns about H1N1 influenza and their desire to protect 

themselves and their families. The fraudulent products come in all varieties and 

could include dietary supplements or other food products, or products purporting to 

be drugs, devices or vaccines. 

FDA has an aggressive strategy to identify, investigate, and take action against 

individuals or businesses that wrongfully promote products in an attempt to take 

advantage of this current public health emergency. FDA issued warning notices to 

more than 30 Internet sites that we believe are wrongfully promoting products to 

consumers. We have also invited the public to voluntarily report suspected criminal 

activity, Websites and other promotions for products that claim to diagnose, prevent, 

mitigate, treat or cure the 2009-H1N1 influenza virus. 

Fiscal Year 2006 Influenza Pandemic Funding 

As I mentioned in my May 7, 2009 testimony, during fiscal year 2006 this subcommittee had the foresight to appropriate $20 million to FDA for pandemic influenza preparedness in an emergency supplemental appropriation. FDA invested pandemic influenza supplemental funding in three key areas that are critical to America’s preparedness for an influenza pandemic: strengthening our capacity to expedite 

the development of flu vaccines, conducting essential monitoring and inspection of 

flu vaccine manufacturers, and conducting FDA-wide pandemic planning and preparedness activities. This $20 million supplemental became part of FDA’s base resources and allowed FDA to achieve a higher state of preparedness for events like 

2009-H1N1 Flu Virus outbreak. Because of the work begun in 2006, FDA is better 

prepared for today’s response to the 2009-H1N1 Flu Virus. 

CONCLUSION

Our fiscal year 2010 budget of $3.2 billion will allow FDA to strengthen the safety 

of the food supply and to anticipate and address safety signals that emerge from 

the use of the drugs, biologics and medical devices that FDA regulates. Our fiscal 

year 2010 increase will allow the dedicated professionals at FDA to help ensure that 

Americans benefit from a safe and wholesome food supply and from medical products that sustain and improve their lives. Achieving our mission is possible because 

of your support for the work of the Food and Drug Administration. 

Thank you very much for the opportunity to testify. I welcome your ideas and 

your questions. 

Senator KOHL. Thank you very much, Dr. Sharfstein. You’ve 

been the Acting Director now for some 6 or 8 weeks. Very soon Dr. 

Hamburg will come become the Director and you will be bumped 

down to Number 2. Are you looking forward to that, Dr. 

Sharfstein? 

Dr. SHARFSTEIN. I think, with the possible exception of Dr. Hamburg herself, I may have been the most happy person to see her 

confirmed by the Senate. 

Senator KOHL. You mean you don’t like having to respond to us 

directly? 

Dr. SHARFSTEIN. You know, I was very, very pleased to be able 

to represent the agency at this hearing, I’ll tell you that, but it is— 

and it has been a tremendous honor and I think I have had the 
15 

incredible opportunity to get to know Dr. Hamburg over the last 

couple months and I’m just really excited to work for her. 

Senator KOHL. Good. If asked for your judgment on the adequacy 

of this budget request, what would you say? Is it enough? 

Dr. SHARFSTEIN. I think it’s enough for major progress for FDA. 

SUPPLEMENTAL FUNDS

Senator KOHL. All right. Last year FDA was provided with a 

$150 million in supplemental funds. As of March 31 only $30 million has been obligated. These funds expire now in just 4 months. 

Can you expect to responsibly spend this additional money in 

that brief period of time and how? 

Dr. SHARFSTEIN. Sure. I do believe we can expect to responsibly 

spend that, and I’m going to ask Patrick McGarey to talk about 

some of the details, but before I do that, I think it’s important to 

note that there are a couple major efforts that are going forward 

to spend that money, one of which has been the hiring. 

HIRING AND IT

FDA has hired quite a number of new staff and that is continuing pretty briskly, but the other major one is information technology investments and what is going on now is that the agency 

has been working to best define those investments and then it will 

make those investments and it will lock up the money, but the 

thinking, the thought behind those investments is what’s the reason that it wasn’t spent yet, but it will be spent and it will be put 

into, you know, kind of the contracts and other vehicles that will 

bring those investments about, and those are things that seem 

pretty basic in some cases. 

People can file their submissions electronically and then people 

can file for adverse events reports electronically and the agency can 

have a better opportunity to investigate things or things that are 

really essential to kind of have FDA in a modern regulatory agency’s position, and I think that the agency’s been doing the right 

thing to think carefully about those investments and I know Dr. 

Hamburg is going to want to take a look at them and then when 

we’re really sure that’s when we’ll pull the trigger on tying up 

those funds. 

Patrick, is there anything else you want to mention? 

Mr. MCGAREY. You covered it very well. We expect, with our IT 

investments, which are the heaviest piece, to launch in the coming 

quarter—excuse me—that the IT investments will launch in the 

coming quarter and there will be a large amount that will move 

into priority IT areas. I think that just buttresses what Dr. 

Sharfstein said. 

STRATEGIC FRAMEWORK

Senator KOHL. All right. Dr. Sharfstein, does the $14.6 million 

‘‘strategic framework’’ for food safety include implementation of 

FDA’s Food Protection Plan? Can you provide some detail on this? 

In particular, will the FDA need to change its structure or its current activities? 
16 

Dr. SHARFSTEIN. $14.6 million, I think, relates to what we’d like 

to do with States and localities, and this is a multiyear investment. 

It’s really to transform FDA’s relationship with States and localities on food safety so that when the State—I recently met with a 

company that said on Monday they get a Federal inspection, sometimes Tuesday they get a State inspection, on Wednesday they get 

a local inspection and sometimes they’re done by the same person, 

you know, who just pulls out a different clipboard and is, you 

know, checking stuff down. 

We hear all this about there not being enough inspectors but 

what’s going on, and it’s a fair question, and I think it’s very clearly understood that there’s not the kind of coordination. By coordination, I don’t mean just the FDA hiring the State contractors 

which is what goes on now, to a certain extent, but really it’s an 

integrated system where if the State goes out, FDA has confidence 

that that inspection is good. 

And there was really a report that was funded by the Robert 

Wood Johnson Foundation that really set out a vision for that kind 

of system and this is really a big step, this $14.6 million, to start 

to move to that. It’s going to require FDA to develop a significant 

training capacity. It’s going to require States to want to engage. 

There’s some money in there for the States to be able to spend 

money, to hire people, to upgrade their level of food inspections, 

and I think that is going to pay off a lot. 

There’s something like $700 million of States and localities 

spending on food inspections now, but if FDA doesn’t have the confidence and if there are gaps in those inspections or they’re not at 

the right, you know, level, then that money is not being spent as 

well as it should be. 

If we can invest some in increasing the training and we can give 

some money to States to be able to do it, then we’re leveraging that 

$700 million to really strengthen the overall food safety system. 

Now to your point on the FDA’s organization, I think that’s 

something that I know Dr. Hamburg and I are going to look at very 

seriously. I think it’s clear that the responsibilities for food are 

stretched over different areas of FDA. 

One thing that I’ve done since I began is every morning at 7:45 

I bring everyone related to food, that’s the Office of Regulatory Affairs, the Associate Commissioner for Food, the SIFSAN, the Center for Veterinary Medicine, together and we have met on different 

food safety issues and that includes active outbreaks as well as policy issues. 

On Thursdays we do a call with USDA and on Friday we do a 

call with CDC, I think since day three on the job. So I think that 

we’ve started the process of pulling the food together, and I think 

we’re going to be looking with Dr. Hamburg’s confirmation at structural issues that could facilitate that. 

Senator KOHL. Good. Senator Brownback. 

Senator BROWNBACK. Thank you, Mr. Chairman. I appreciate 

that. 

ACCESS ACT

On the new drug—this Access Act, I put this bill forward with 

various co-sponsors, bipartisan bill, over a number of years. 
17 

Why can’t the agency do this? It just seems almost inhumane 

what we’re doing to some people that don’t have another option, 

and I want you to have safe drugs out there. There’s no question 

about it, but if somebody’s in a terminal situation with cancer or 

another disease and there is something here that they could try 

that’s showing some promise early, they’re in many cases not able 

to get into clinical trials because they’re not healthy enough to get 

into clinical trials, why can’t we do this? Why can’t you do that? 

Dr. SHARFSTEIN. Thank you. I think that’s an absolutely reasonable question to ask, and I have, you know, met with patients who 

have faced incredible challenges and sometimes it’s been experimental therapies that have been the things that have saved their 

lives. 

EXPERMENTAL DRUGS

I think that there are three different issues that I want to tease 

out. The first is communication. There are—FDA has the responsibility to make the pathways that are available to get experimental 

drugs as widely available as possible. So FDA—it’s very important 

that there are different mechanisms that doctors and companies 

can use to access drugs in the pre-approval stage and it’s important 

and one of the things we’ll be focusing on is making sure that those 

mechanisms are as widely available as possible. That’s just one of 

three points I want to make. 

The second one is data, and I’ve been impressed and I’ve talked 

to people on all sides of this issue, had extensive conversations 

with people who are very strong supporters of your legislation, and 

I’ve also met with people who have different views on it, and the 

one thing that struck me is how little data we have on what the 

barriers are, what the point of the barrier is, and what I mean by 

that is I’d like to know, walking into this discussion, of 500 patients with severe, you know, life-threatening illness who want experimental drugs who can’t—you know, what percent get them either by enrolling in a trial or, you know getting them through one 

of the existing pathways at FDA? 

What percent is it that the company is not willing to apply for 

an IND or some mechanism or they are applying and FDA is not 

granting it, and so, I mean, to me having some basic data to understand this, and what I’ve found is that people around this issue on 

all sides all agree that there is need for more data there, and some 

of that, I believe, exists within FDA, and we should be able to get 

that. 

We should—I would like to know when people do apply for these 

INDs what the rate of approval is and when we’re approving them 

and when not and why. So I think that that’s got to be part of what 

informs policy. 

Senator BROWNBACK. And you’re going to start shaping that 

database? 

Dr. SHARFSTEIN. Yes, I do want—one of the goals is to get data 

that allow us to identify the point, the rate-determining step. I’m 

not sure exactly what that is. 

And the third thing is flexibility and I think both Dr. Hamburg 

and I are going to go into this with an open mind about it. I do 

understand the issue that it’s very important for there to be data 
18 

about the effectiveness of new drugs because without that data, 

you—— 

Senator BROWNBACK. It’s the Wild West on the Internet without 

that data. 

Dr. SHARFSTEIN. Right. 

Senator BROWNBACK. I mean, it’s just people putting all sorts of 

things out there and when you’re in that type of situation you’re 

willing to listen to about anything. 

Dr. SHARFSTEIN. Well, there’s a very, you know, disturbing report 

in the Chicago Tribune about an approach that people are using for 

autism that a lot of people feel like is potentially dangerous to kids 

and, you know, you have to—FDA has a responsibility on both 

sides, a responsibility that people aren’t exposing themselves to, 

you know, risk without benefit but also where there is benefit and 

people can make a reasonable decision to help them do that, at the 

same time understanding the need for, you know, real evidence 

about the products. 

Senator BROWNBACK. I hope we can work with you and the incoming Director of the FDA to maybe get some of these specific 

steps taken care of so we can make it more accessible. 

Dr. SHARFSTEIN. I’ll tell you, I talked to David Kessler before I 

took this job and what he said to me was when he looks back on 

his time at FDA, the thing that he’s most proud of is getting the 

medications for HIV patients. 

Senator BROWNBACK. Yeah. It was a fabulous move and they 

really sped it up and thankfully because they did people lived and 

now we’re slowing it down for a lot of others and people die. 

I can get you the studies from the groups and I’m sure you’ve 

seen these numbers of tens of thousands of people dying waiting 

for a drug to get on the market and in many cases that is eventually approved and then they die waiting and that’s what just—you 

look at it and you think that’s just cruel. 

But I hope you can work with us on this because I thought what 

Kessler did was spot on when he looked at this real crisis that was 

existing and we’ve got a cancer crisis now. I hope you can work 

with this on that. 

Thanks, Mr. Chairman. 

Senator KOHL. Thank you very much, Senator Brownback. 

Senator Pryor is here from Arkansas. Senator Pryor, you have a 

full 5 minutes. 

NCTR

Senator PRYOR. Thank you very much, Mr. Chairman. Thank you 

for your leadership on this. 

Let me ask, if I may, Dr. Sharfstein, about an FDA facility that’s 

actually located in my State, the NCTR, National Center for Toxicological Research. Are you familiar with that center? 

Dr. SHARFSTEIN. Yes, not only that, I think its director is behind 

me here. 

Senator PRYOR. Great. And—— 

Dr. SHARFSTEIN. I’m looking forward to visiting. 

Senator PRYOR. Good. Well, I know that the administration’s 

asked for $1 million to do some nano research there, to research 

the effects of nano technology which I think is important research, 
19 

and I think it needs to be done because obviously nano technology 

offers a lot of promise in the future, but we need to be very clear 

about the health risks before we go forward. 

And my question for you is, if you know, is $1 million enough to 

do an adequate job or at least get an adequate start on that research? 

Dr. SHARFSTEIN. Let me just check. I think that the money actually pays for some pretty important equipment. I think it is going 

to pay for if not an electron microscope then the actual materials 

to support the electron microscope and an electron microscopy technician. 

So it allows the—it’s sort of an investment in the ability of NCTR 

to do critical research on nano technology, and I think your point 

is extremely important and this is, I think, a point that is very important for FDA generally. This is a new field and if there’s an unforeseen safety problem, it could really hurt the field, but by having good data and doing sensible regulation, then we provide confidence to that field. It can grow. It can become a big, you know, 

improve—you know, could create all sorts of products that are beneficial to public health. 

So this is not a situation where regulation and the, you know, 

interests of industry are at odds. In fact, if we can do sensible regulation, we establish safety, then you could imagine that, you know, 

20 years from now people would be looking back and seeing it as 

just the birth of a whole movement in nano technology. 

Senator PRYOR. Right. And the other part is not just nano products generally but I know there’s some real potential for medical 

breakthroughs using nano technology. 

Recently, I saw that there was an announcement that you can 

somehow get carbon nano tubes and they think that they can be 

a very accurate treatment for cancer that doesn’t harm the rest of 

the body but then again, I think the other health research needs 

to be done on that. 

You have a very promising technology, you know, very promising 

development with nano technology. You just need to make sure 

that it’s not harming others. 

Dr. SHARFSTEIN. Well, I agree, and I think this is an area where 

you have something that’s so promising. Part of FDA’s job is not 

just to sit back and see what happens but to really engage in the 

conversations and try to facilitate. 

Senator PRYOR. Right. That’s right. You mentioned in your testimony a few moments ago that you have a consumer team at FDA 

and you’re doing warning letters to companies that are selling, I 

guess, sounds like maybe miracle cures on the H1N1? 

Dr. SHARFSTEIN. Correct. 

Senator PRYOR. And I’m just interested in that. I think you said 

you sent out 31 letters, and is it possible for you to provide the 

committee with copies of those letters so that we could know who’s 

out there doing that? 

I’m chair of the Consumer Subcommittee over in the Commerce 

Committee. So I’d like to get those. Is there any real update on 

that or is there any status report you want to give us? 
20 

WARNING LETTERS

Dr. SHARFSTEIN. Yes, I think the latest information I have is that 

there were 36 warning letters and we’d be happy to provide them 

to you, and I think there’s 69 products cited in the warning letters, 

and I mentioned a couple of them, one of which says that independent tests show this product is hundreds of times more effective 

at killing the flu virus than the most potential antiviral prescription medications known. It’s the only one that actually kills the 

virus and automatically eliminates all symptoms. That’s one. 

[The information follows:] 

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm 

Senator PRYOR. Right. 

Dr. SHARFSTEIN. The other says it’s good for swine flu, bird flu, 

MRSA, SARS, malaria, anthrax, TB, Bubonic plaque and sexuallytransmitted diseases. 

So I think that there’s a whole list of them and, you know, on 

the one hand, maybe if it’s totally harmless, you know, you think, 

well, you know, why waste—why spend resources in that direction, 

but the truth is somebody who’s sick and maybe they don’t even 

have swine flu, somebody who’s sick may be turning to products because of the claims that they’re making and not going to the doctor 

and potentially getting worse, and, you know, it’s important that 

people not be misled by inappropriate information. 

Senator PRYOR. Right. I would encourage, if you could, you to 

work with the Consumer Product Safety Commission, even though 

you’re talking about drugs. They have a lot of expertise in tracking 

that and trying to prevent those types of scams and rip-offs. 

DRUG IMPORTATION

One last question, if I may, and that is about importing drugs. 

There’s been a question here in years past about how safe imported 

drugs are into this country and as I understand it, the president 

is trying to work with stakeholders to develop a policy on imported 

drugs. 

Do you know anything about? 

Dr. SHARFSTEIN. Sure. So there are two issues. I think a lot of 

drugs in the United States—drug supplies are imported now in the 

sense that they’re manufactured abroad or they have materials 

that are manufactured abroad and there’s a whole issue of safety 

there that’s very important to deal with. 

The second issue is the purchase of drugs that are approved in 

other countries, so not drugs that are FDA-approved but drugs that 

are approved, say, by the regulatory authority in Canada, for example, and whether it is appropriate, safe, to design a system that 

would permit importation of drugs approved in other countries as 

opposed to the importation of U.S. drugs which happens all the 

time. 

And what the budget has is $5 million for FDA to develop a 

framework and a policy that could permit that to be done safely. 

So I think—so basically, we would spend some time thinking 

through what the challenges to that kind of system would be and 

try to design an approach to solve those challenges and I think one 
21 

of the benefits to this is that some of the issues there are going to 

be relevant to the first problem, too. 

So no matter what we find, it’s going to be helpful to us. If we 

are trying to understand more about how to trace the pedigree of 

drugs so that we can be sure we’re getting true drugs from other 

countries, that’s going to help us understand how to do that well 

in the United States, too. 

So I think there’s a crossover benefit of that project. 

Senator PRYOR. Okay. Thank you, Mr. Chairman. 

Senator KOHL. Thanks a lot, Senator Pryor. Senator Bennett. 

CRITICAL PATH

Senator BENNETT. Thank you very much, Mr. Chairman, and my 

question will come as a great surprise. 

Tell me about the Critical Path and what you see and what your 

attitude is and what you think the ongoing attitude will be. 

Dr. SHARFSTEIN. So I think—thank you. I think the Critical Path 

has been a very important effort by FDA and it’s something that 

I believe Dr. Hamburg supports, and I certainly support. 

I think the question is what is the Critical Path going to mean 

and in talking to the people who run it and in talking to Dr. Goodman, who’s now the Acting Chief Scientist and is here, I think that 

we see the Critical Path as a way to do very important partnerships that permit breakthroughs in diagnostics and in treatment 

and so there’s a lot of important work. 

It’s not just the job of the Critical Path to think about basic 

treatment. That’s the job of FDA. I mean that’s the job of a lot of 

different people. 

Senator BENNETT. Sure. 

Dr. SHARFSTEIN. The role of the Critical Path is to think of partnerships and one of the examples of that is this study that is one 

of the things that was funded by the support that we have received 

in increases in the last couple of years, that FDA is facilitating 

working with partners that design and conduct a large trial to compare the benefits of extended anti-platelet therapy versus aspirin 

alone in patients receiving stents, and this is a study that will really answer some pretty important questions. It’s being overseen by 

the Critical Path team because of the nature of the partnership 

that’s there. 

So I think that what I also liked about the Critical Path particularly is that it naturally is connecting its investments to the outcome, and I think that’s something that, in general, FDA needs to 

do better. We’re getting all this money. What are we delivering? 

And what I like about the Critical Path and I’ve got the report 

you may have seen, Projects Receiving Critical Path Support in 

Fiscal Year 2008, and what it does is say, look, you gave us this 

money, here’s what we’re doing and if it works, here is what we’re 

going to get for it, and I think that that is—it’s important to—the 

Critical Path serves the role of pushing that thinking all the way 

into FDA. 

So I think that you’re going to see support for that at FDA and 

I think I’d like to have a very clear philosophy articulated and then 

lots of clear things that we’re delivering on that benefits the public 

health. 
22 

TOBACCO

Senator BENNETT. Thank you. An unrelated question. There is a 

very strong push going on, which I expect will probably succeed in 

this Congress, to give FDA jurisdiction over tobacco. 

I’ve always resisted that on the grounds that FDA is an agency 

that has as its goal determining whether or not things are safe and 

you can determine whether or not tobacco is safe or healthy in an 

afternoon. But now you’re going to ‘‘regulate’’ tobacco and it’s a new 

role for FDA. 

Do you have any idea as to exactly what FDA would do with respect to regulating tobacco, and how much of a burden it will put 

on FDA personnel if the bill with respect to tobacco and FDA 

passes? 

I clearly am one who wants to do everything I can to get people 

to stop smoking because it’s one of our biggest health problems in 

the United States. My concern has absolutely nothing to do with 

that. It has to do with FDA as the suitable agency, but it looks like 

I’m going to be overruled and I probably will end up voting for the 

bill anyway because I don’t want to be accused of being in favor 

of big tobacco simply because no other agency presents itself as the 

one to deal with it. So you’re going to get stuck with it. 

Now, do you have any insight for us as to how it’s going to work 

and what you’re going to do? 

Dr. SHARFSTEIN. Thank you, and I think it’s—obviously given the 

circumstances and the legislation moving forward, I totally understand the question. 

To your point about the—it being a little unusual for FDA to be 

regulating something that is clearly unsafe, I think that the bigger 

picture is that FDA is a public health agency and takes a lot of 

steps in terms of regulating products to improve the public health, 

and I think that’s the approach that would have to be taken for tobacco, which is the leading cause of preventable death and also one 

of the least regulated products in the market. 

I do think that the—we’re going to have to read very carefully 

the bill that’s passed by Congress, and I think what we would do 

is going to depend on the final shape of the legislation and still 

hasn’t gone to the Senate Floor, and I know there may be all sorts 

of amendments and changes and, you know, our job is to implement the legislation that Congress has passed. 

So I think that there is a budding science, science that I think 

we can expect to grow over time, about what about tobacco may be 

responsible for different adverse problems that result from tobacco 

and as that science grows, FDA will be in a position to make different types of tobacco products less harmful, and I think that’s one 

area that the bill definitely contemplates as it’s written now, to 

allow the agency to establish performance standards in different 

areas, but that’s going to depend on the scientific findings and the 

approach the FDA would take to this is going to be, you know, 

weighing the risk and the benefit of different approaches for things, 

as the FDA often has to do, in completely different contexts. 

As far as the burden question, I think that’s obviously a fair 

question because FDA has a lot to do. Otherwise, I think that it 

is—I think that the administration believes, Dr. Hamburg believes, 
23 

and I believe that the FDA is the right agency for this task, given 

the experience the FDA has in regulation and some of the expertise 

in particular elements. 

Even if it’s not, you know, cigarettes, when you have a toxicology 

issue, if you have toxicologists, they can helpful. They can help you 

figure out what the right team to have there is. 

I think the bill has got to provide adequate resources and the 

current version does for the agency to do the work and with that, 

I think what Dr. Hamburg has said is that we have to be—you 

know, the agency already has to be able to do more than one thing 

well at once, and this is going to be another thing but it’s a very 

important thing. 

In the big picture, it’s going to improve the health of Americans 

and for that reason, I think it’s important. 

Senator BENNETT. Thank you very much. I’m encouraged. 

Thank you, Mr. Chairman. 

SAFE DRUG USAGE

Senator KOHL. Thanks very much, Senator Bennett. 

Dr. Sharfstein, the FDA recently acknowledged that prescription 

drug information provided to consumers at the pharmacy can be 

very bewildering and not easily understood. Your budget proposes 

$3.4 million to promote safe drug usage. 

Will these funds be used to address that problem I just described, and what process and time table will FDA be using to 

make sure that consumers get streamlined easy-to-understand language when they buy their prescription drugs? 

Dr. SHARFSTEIN. Thank you. It’s a very good question because 

there’s information that comes about drugs from multiple different 

sources. You see the ads, the handouts which can be like, you 

know, the actual package inserts which can be very small print and 

difficult to understand, then there’s things that people get in the 

pharmacy. Sometimes they’re approved by FDA and sometimes 

they’re not and they can be potentially misleading sometimes. So 

I think the point you’re raising is important. 

The Safer Drug Initiative has a goal of working collaboratively 

with a lot of external partners, including pharmacies, to get better 

information and instructions to people. It relates not just to information but also things like how to keep medicines at home, how 

not to let kids into medicines and a whole bunch of other things 

that can have a big impact on health if they’re followed through on. 

As far as the particular projects and timing, I think I might want 

to ask Dr. Woodcock, who is here, the head of the Center for Drugs, 

to answer that, if that’s okay, or if you prefer, we can provide more 

of an answer. 

Dr. WOODCOCK. Hi. I’m Janet Woodcock. Yes, we agree, and as 

you alluded to, at a recent public meeting we talked about the survey that had been done, a scientific survey by contractors of consumer information that is given to people when they fill prescriptions, and it did not meet the criteria for usefulness for patients 

that had been established. 
24 

MED GUIDES

So we are going to be going through the next year through a 

process and we’re going to look not just at that consumer information but, as Dr. Sharfstein alluded to, to med guides and to patient 

package inserts and all these different forms of information that 

people can get and try to craft something that is maximally useful 

to people who fill prescriptions and have to take medicine. 

Senator KOHL. That’s good. Thank you. 

Senator Brownback. 

Senator BROWNBACK. Thanks, Mr. Chairman. 

COST OF DRUG DEVELOPMENT

Dr. Sharfstein, just one final comment area. I’m very troubled 

about the cost of developing a new drug nowadays and I’m hearing 

now pharmacy schools, University of Kansas School of Pharmacy is 

one of the top in a number of different surveys, the top pharmacy 

school in the country, saying that the cost of drugs, the cost of developing a drug is so high now that whole categories are not even 

particularly being focused on because there’s not a big enough patient pool to support the research dollars that’s necessary, in the 

hundreds of millions, I suppose even billions, of dollars, to bring 

out some new drugs. 

I very much appreciate the focus on safety and we need to have 

that, but now if we’re shutting off to the side a potential drug development because it only had 300,000 patients or 1 million potential patients and you spread the costs of $1 billion drug over them 

and they’re saying we can’t do it, I would hope that you and the 

new team that comes in at FDA would look at this and say this 

is a major problem for us because now we’re going to have whole 

areas where we’re not even going to be researching what you put— 

how you try to treat this and if you get it, you know, God save you. 

I’m hopeful it becomes better. I really hope you look at that and 

I also want to invite you out to the KU Pharmacy School. I just 

toured there not long ago and I think they’re doing some really fascinating work on screening throughputs of different compounds on 

a very rapid basis and I’m sure you’re familiar with the technique. 

I was impressed with it, though, and the way they’re looking at 

these items, and I do hope you really get on top of that cost issue 

because it’s going to kill people if we don’t get on top of it. 

Dr. SHARFSTEIN. Thank you. I know that Dr. Hamburg has a special interest in orphan drugs and drugs for diseases that don’t, you 

know, affect as many people as sort of the major drugs. 

I know in the last couple years FDA’s approved a couple drugs 

under the Orphan Drug Program, including a drug for Huntington’s disease and a drug for Hunter’s disease, and I remember taking care of kids with that. But it’s something that requires and will 

get attention from us to understand what needs to happen. 

I was just at an event for the National Organization of Rare Diseases and, you know, I heard from everybody the concern that 

you’re raising and I think both Dr. Hamburg and I are going to be 

very interested. 

I think that when you think about FDA, the role of FDA, it’s 

both about benefit and risk. In other words, we want to maximize 
25 

the benefit, we want to help get drugs to people who need them 

and at the same time we want to reduce the safety concerns, and 

both parts of that equation are very important to us. 

Senator BROWNBACK. I want to invite you out and we’ll give you 

a cholesterol-free steak,—— 

Dr. SHARFSTEIN. Okay. Sounds good. 

Senator BROWNBACK [continuing]. Top quality. Thanks, Mr. 

Chairman. 

ADDITIONAL STAFF

Senator KOHL. Thanks a lot, Senator Brownback. 

Dr. Sharfstein, will you tell us a little bit about your plus-up in 

staff by quite a few hundred and what you’re going to let them or 

direct them to be doing? 

Dr. SHARFSTEIN. Sure. In the fiscal year 2010 budget, you mean? 

Senator KOHL. Yes. 

Dr. SHARFSTEIN. Let’s see. I think that the total number—— 

Senator KOHL. It says here you have 678 additional staff to work 

on food safety and some few more hundred to work on medical 

product safety. 

Can you confirm that and tell the American public that you really are adding people to work on the issues of food safety and food 

inspection and—— 

Dr. SHARFSTEIN. Yes, the—for foods, it’ll be about 220 more inspectors as well as analysts and a total of about 600 or so of people 

to work on foods. For medicines, it’s going to be about, as I said, 

300 more people and that includes a lot of scientists who will be 

working to make sure that drugs, vaccines, tissues, devices, are 

safer and we understand the opportunities for new novel products 

better. 

So I think that these investments, we should see and we should 

be able to explain clearly to you and to anyone who asks how we’re 

using these investments not just to hire people and not just to get 

inspections, for example, but to actually deliver results that matter 

to people. 

Senator KOHL. Your Rapid Response Program, how’s that working? 

Dr. SHARFSTEIN. For food safety? 

Senator KOHL. Yeah. The food outbreaks. 

Dr. SHARFSTEIN. Food outbreaks? 

Senator KOHL. Yes. 

Dr. SHARFSTEIN. I think that I’m familiar with how we responded 

to the food outbreaks that I’ve been involved in, but I might ask 

David Acheson to come forward and talk about that particularly. 

I’m not sure what part of that is referred to as the Rapid Response Program. 

What we have done and I’ve seen is that FDA has been working 

very closely with the States and localities. We are involved with 

CDC and with the industry when there’s an issue and it’s moved 

very quickly so that we’re able to narrow the scope of the pistachio 

recall very quickly and the scope of the alfalfa sprout very quickly. 

It was because of coordinated action among those different groups. 

And let me see if—it would be Dr. Acheson. 
26 

Senator KOHL. We have just a minute or so before we have to 

end. 

RAPID RESPONSE

Dr. ACHESON. Good afternoon. I’m David Acheson, Associate 

Commissioner for Foods. 

I think you’re probably referring to the Rapid Response Teams 

that we’re putting out in the States. 

Senator KOHL. That’s correct. 

Dr. ACHESON. And we’ve now got six of those funded with the 

machinery operating to fund another three. This is all part of the 

integrated FDA-State-local systems that are—this is obviously focused on response and that’s clearly at the end of the spectrum, but 

that’s beginning to work very well and bear good fruit, and we’re 

targeting working with the States much earlier in these situations 

and not waiting until it’s later. 

ADDITIONAL COMMITTEE QUESTIONS

Senator KOHL. Thank you. Well, Dr. Sharfstein, we want to 

thank you and your staff for being here today. 

I believe the FDA is going to become increasingly responsive to 

all the important needs in our society under your direction along 

with Dr. Hamburg, and we are looking forward to working with 

you. 

[The following questions were not asked at the hearing, but were 

submitted to the Department for response subsequent to the hearing:] 

QUESTIONS SUBMITTED BY SENATOR HERB KOHL

FDA’S NEW PLAN FOR FOOD SAFETY AND STATES’ ROLE

Question. What do you think is the appropriate role of States in this effort? It appears that funding for State contract inspections is increasing very slightly. Should 

that number go up? 

Answer. For fiscal year 2010, FDA is requesting funding for a new strategic 

framework for an integrated national food safety system. A system that has adequate Nation-wide coverage will require implementation across multiple years. For 

fiscal year 2010, FDA is requesting $14.61 million to begin to build the FDA infrastructure for the system. 

The States will play a central role in the strategic framework for an integrated 

national food safety system. FDA’s fiscal year 2010 investment in infrastructure is 

essential to help establish the standards, training, accreditation and oversight programs that are integral to an effective system, to leverage State regulatory programs, and to ensure consistent standards among regulatory partners. 

Question. What percent of FDA food inspections are carried out by State inspectors through a contract? 

Answer. During fiscal year 2008, FDA and our State partners conducted 16,125 

domestic food inspections. Of this amount, State inspectors under contract to FDA 

conducted 8,777 inspections, or 54 percent of the total. If animal feed inspections 

are added to the count of food inspections, State inspectors under contract to FDA 

conducted 14,489 or 60 percent of the 24,037 domestic food and animal feed inspections. FDA also has responsibility over FDA-regulated products entering the United 

States. During fiscal year 2008, FDA inspected 152 foreign food establishments and 

completed 100,718 import field exams. 

Question. What percent of FDA medical product inspections are carried out by 

State inspectors through a contract? 

Answer. During fiscal year 2008, FDA and our State partners conducted 13,588 

domestic medical product inspections. Of this amount, State inspectors under contract to FDA conducted 7,652 inspections, or 56 percent of the total. The State contract inspections consist of 13 medical device inspections and 7,639 medical product 
27 

mammography facility inspections conducted as part of the Mammography Quality 

Standards Act. In the case of non-mammography inspections, State inspectors conducted less than 1 percent of non-mammography inspections during fiscal year 2008. 

Question. The budget says this new system may require new authorities, including multi-year budget authority. I don’t see this request in the budget. Can you 

elaborate? 

Answer. FDA is requesting $14.61 million to begin to build the FDA infrastructure for an integrated national food safety system. These funds will allow FDA to 

establish the standards, training, accreditation and oversight programs that are integral to an effective system. FDA cannot establish an integrated national food safety system during a single fiscal year. We hope to continue to build this system over 

time. 

Question. Recent reports have highlighted FDA’s failure to properly audit State 

inspection programs. Is there funding in the budget to increase these audits? 

Answer. Yes, the request to increase funding to enhance our audit program for 

State inspections is part of the funding request for the Integrated National Food 

Safety System. Enhancing our audit program will allow FDA to increase the audit 

staff conducting oversight of State food safety inspections. 

Question. Will all of the additional food inspections be carried out by FDA inspectors, or will some of them be through State and other contracts? 

Answer. Additional food inspections will be carried out by FDA investigators. The 

fiscal year 2010 budget increase will allow FDA to hire additional investigators to 

increase the number of domestic and foreign inspections that FDA conducts. 

For the fiscal year 2010 budget increase, FDA estimates that it will hire approximately 126 more investigators with Budget Authority and approximately 96 more 

investigators with Food Inspection and Facility Registration User Fees to conduct 

domestic and foreign food safety inspections. Due to the time that it will take to 

train the new FDA investigators, FDA will not achieve the increase in domestic inspections until the end of 2012. FDA will achieve an increase in foreign inspections 

associated with the additional investigators by the end of fiscal year 2012. The fiscal 

year 2010 budget increase will allow FDA to use Budget Authority to conduct 2,000 

domestic and 50 foreign inspections. In addition, FDA will also use Food Inspection 

and Facility Registration User Fees to conduct an additional 2,000 domestic and 50 

foreign inspections. This will achieve a total of 4,000 additional domestic food safety 

inspections in fiscal year 2012 and 100 additional foreign food safety inspections in 

fiscal year 2012. 

RAPID RESPONSE TEAMS

Question. The budget includes $12 million to accelerate responses to food borne 

outbreaks. What specifically will this money be for? 

Answer. The $12.1 million increase that you identify will allow FDA to increase 

its laboratory capacity to support food safety activities. These funds will not be used 

to increase the number of rapid response teams. The $12.1 million will allow FDA 

to fund three additional chemistry labs for the Food Emergency Response Network—FERN—and provide additional support to State microbiology laboratories in 

the FERN system. 

Question. How many rapid response teams have been created throughout the 

country, and where? 

Answer. At this time, there are six rapid response teams. The teams are in California, Florida, Massachusetts, Michigan, Minnesota, and North Carolina. FDA is 

in the process of awarding cooperative agreements to establish three additional 

rapid response teams before the end of 2009. 

Question. Please provide a summary of the activities of the rapid response teams 

to date. 

Answer. All teams completed initial developmental activities, which included 

training and an assessment of their response capacities. By July of 2009, all teams 

will have participated in 2-day FDA sponsored training sessions. By September, all 

teams are due to complete their Manufactured Foods Regulatory Program Standards 

Assessments. 

The participating States are at varying stages of their plans to acquire additional 

team members, to provide training to support team objectives and to initiate practice exercises to prepare the team. Additional training opportunities consist of other 

courses provided by FDA and relevant courses supplied through other qualified 

sources. All States are meeting the milestones set out under the cooperative agreements. 

The six participating States entered into the Rapid Response Teams pilot cooperative agreements with FDA with varying degrees of established team experience and 
28 

structure. Several States had already invested in developing team structures while 

others are using the resources available through the FDA agreements to initiate 

teams this year. These different experience levels across the six State teams have 

yielded some States with the capability to activate teams in this first year of the 

agreement. States with developed and practiced teams have deployed them in response to State level incidents and incidents under FDA jurisdiction, such as the 

coordinated response to Salmonella in peanut butter earlier this year. The remaining States continue to obtain training, develop procedures, and prepare for practice 

exercises. 

GENERIC DRUGS

Question. Even though Congress has provided increases over the last few years 

for generic drug review, the backlog of applications continues to grow. The user fee 

being proposed has been proposed in previous budgets, but never authorized. Do you 

think this year will be different? If the user fees aren’t enacted, is the budget for 

generic drugs adequate? 

Answer. Although generic drug user fees have been proposed in previous budgets, 

FDA plans to reengage the generic drug industry in user fee discussions this year 

to make progress on this important proposal. Our aim will be to develop a user fee 

program that provides the FDA generic drug program with the resources needed to 

modernize and enhance the capacity of the generic drug review process and to ensure timely patient access to safe and effective new generic drugs. FDA believes that 

the resources in the fiscal year 2010 proposed generic drug user fee program are 

necessary to reduce the review backlog and ensure patient access to safe and affordable generic drugs. 

NEW AUTHORITIES REQUESTED IN THE BUDGET

Question. There are no details in the budget regarding the new authority for generic biologics. What is the status of this, and is there an associated cost? 

Answer. The fiscal year 2010 Budget supports the creation of a new regulatory 

pathway under the Public Health Service Act for FDA approval of ‘‘generic biologics,’’ a term that refers to follow-on biological products that are highly similar 

to—or biosimilar—and may be substitutable or interchangeable for a previously approved biological product. As I mentioned in my testimony, establishing a generic 

biologics pathway will require new legislation. 

FDA has approved follow-on versions of certain protein products under the existing abbreviated approval pathways in the Federal Food, Drug, and Cosmetic Act. 

However, the majority of protein products now on the market have been licensed 

as biological products under the Public Health Service Act, which does not contain 

analogous abbreviated approval pathways. 

Safe and effective generic biologics may prove to be a critical element to lowering 

costs for American consumers and the healthcare system more broadly. FDA would 

require additional resources to augment our existing capabilities for regulatory activities associated with a generic biologics program, and anticipates the need for significant additional analytical testing capabilities. Depending on the scope and requirements of any legislation establishing a generic biologics pathway, we expect 

that there will be a large workload in the early phase of a generic biologics program 

in our pre-application activities—including meeting with industry and providing advice—as well as developing policy and procedures, publishing guidance, and promulgating regulations. We also anticipate receiving some applications for review shortly 

after enactment of legislation, with an increasing number of applications for review 

in subsequent years. 

Question. What is the administration’s plan to get the 4 new user fees you mention in your statement authorized? What are the results if that doesn’t happen? 

Answer. FDA plans to work with the administration, with Congress and with 

stakeholders to authorize the four new user fee programs proposed in the fiscal year 

2010 budget. In the event that our efforts are not successful, FDA will rely on existing funding in the form of budget authority to conduct the four program activities 

without the benefit of additional user fees. 

ADDITIONAL STAFF REQUESTED IN THE BUDGET/PAY COSTS

Question. How many additional staff has FDA hired with the increases provided 

in the supplemental and the fiscal year 2009 increases? 

Answer. FDA has hired 859 additional staff from the funds provided in the fiscal 

year 2008 supplemental and the fiscal year 2009 budget authority and user fee increases. As of May 18, 2009, there were 720 hires on board with 139 staff scheduled 

to start soon thereafter. 
29 

Question. Although the budget includes nearly $30 million for pay costs, it also 

includes a chart that says FDA will have to absorb an additional $33 million to fully 

fund pay costs. How were these numbers developed? If you are only provided the 

$30 million requested, where will the rest of the money come from? 

Answer. The Administration developed the estimate of the total pay cost for FDA 

based on the estimate of the annual pay adjustment for civilian and military employees and the estimate of the numbers of FDA employees who would receive a pay 

increase. FDA will cover any shortfall in the fiscal year 2010 of the annual pay adjustment through a combination of strategies, including reducing operating costs 

and adjusting when it conducts hiring. 

FDA REGULATION OF TOBACCO

Question. As you know, Congress is currently considering a bill that would require 

FDA to regulate tobacco. The bill is proposed to be funded through user fees. However, will there be start-up costs required before the user fees are collected? I don’t 

see any in the budget request. 

Answer. In order to begin implementation of this important program FDA will 

borrow $5 million from its fiscal year 2009 budget authority. This modest sum is 

necessary to establish a process to calculate the amount of user fees due, issue bills, 

and collect fees from covered manufacturers and importers of tobacco products. We 

estimate that we will need approximately four staff to establish the user fee program and there will be associated expenses to adapt our existing IT systems to include billing and collection of these fees. In addition to establishing the user fee program, we would also use these borrowed funds to hire a small number of staff, perhaps 10 or 12 individuals, to begin the work entrusted to the new Center for Tobacco Products. FDA will repay the borrowed funds within 6 months or as soon as 

sufficient user fees are collected. 

ANTIBIOTIC RESISTANCE

Question. I understand that FDA has tested penicillin to see whether or not its 

use in animals results in antibiotic-resistance bacteria that can be transferred to 

people. Are the results of these tests available? Does FDA intend to test other previously approved antibiotics currently being used for non-therapeutic reasons in 

livestock? 

Answer. Although FDA has not conducted tests on penicillin, FDA has conducted 

a review of all available information relevant to assessing the safety of using the 

penicillin class of antimicrobial drugs in the feed of food-producing animals. FDA 

is also reviewing information about other classes of antimicrobial drugs as it is 

broadly concerned about the use of all medically-important antimicrobial drugs for 

production or nontherapeutic purposes in food-producing animals. 

ADULTERATED POMEGRANATE JUICE

Question. What activities has FDA undertaken, or does FDA have planned, in 

order to prevent adulterated pomegranate juice from entering U.S. commerce? 

Answer. FDA is planning to conduct testing of imported pomegranate juice to determine if it is pure pomegranate or contains other materials. We anticipate issuing 

the assignment to test pomegranate juice in the next 3 to 6 months. 

NATIONAL ANTIMICROBIAL MONITORING SYSTEM

Question. What amount is provided in the fiscal year 2010 budget for NARMS? 

Answer. The estimated fiscal year 2010 budget for NARMS will remain at the 

same level it was funded in fiscal year 2009. The fiscal year 2009 amount is $6.7 

million. 

Question. Please describe the activities undertaken with NARMS funding. 

Answer. A key component of the FDA strategy is to assess relationships between 

antimicrobial use in agriculture and subsequent human health consequences is the 

National Antimicrobial Resistance Monitoring System—NARMS. NARMS is a collaborative effort between FDA’s Center for Veterinary Medicine—CVM, the U.S. Department of Agriculture—USDA, the Centers for Disease Control and Prevention— 

CDC, and public health laboratories in all 50 States. NARMS monitors antimicrobial susceptibility/resistance within two categories of enteric bacteria: zoonotic 

bacterial pathogens—Salmonella and Campylobacter—and commensal—not usually 

pathogenic—bacteria—Escherichia coli and Enterococcus. 

NARMS uses comparable testing methods at CDC—human isolates, FDA—retail 

meat isolates, and USDA—food animal slaughter isolates. Samples are tested to determine changes in the susceptibility or resistance of certain enteric bacteria to se-
30 

lected antimicrobial drugs of human and veterinary importance in order to guide 

intervention efforts to mitigate resistance dissemination. The antimicrobial drugs 

tested are selected based on their importance in human and animal medicine. Annual Executive Reports summarizing data from all three NARMS components are 

posted on the FDA NARMS homepage. 

NARMS Salmonella and Campylobacter isolates are subjected to further molecular fingerprinting. This information is submitted to the CDC PulseNet database for 

use in epidemiological foodborne outbreak investigations. The information provides 

public health officials a better understanding of the dynamics of foodborne illness 

attribution in the United States. 

FDA continues to maximize cooperation and communication between FDA, USDA, 

and CDC to increase efficient use of limited resources in database development, 

testing methods and sampling strategies. 

In 2007, the FDA Science Board subcommittee evaluated NARMS. The program 

has evolved into a mission-critical tool for FDA. New pilot projects have proven 

worthwhile and merit further development, and the on-farm data can help to better 

link the human and animal health interface. NARMS scientists continue to address 

and implement many FDA Science Board recommendations. 

METHICILLIN-RESISTANCE STAPHYLOCOCCUS AEREUA—MRSA

Question. Please provide a summary of activities FDA is undertaking regarding 

MRSA. 

Answer. An important role for FDA is providing information on clinical trial designs to study drugs for the treatment of infections due to methicillin-resistant 

staphyloccus aureus, or MRSA. As part of these efforts, on November 18, 2008, the 

FDA Anti-Infective Drugs Advisory Committee convened to provide advice concerning clinical trial designs for testing new drugs for complicated skin infections, 

including those caused by MRSA. The Advisory Committee recommendations focused on feasible non-inferiority trial designs that would provide informative data 

regarding safety and efficacy. FDA also meets with pharmaceutical industry sponsors to provide guidance concerning drug development programs, including those for 

new drugs targeting MRSA. 

FDA reviews investigational new drug applications, or INDs, and reviews and approves new drug applications, or NDAs, and biological license application or BLAs, 

for products for the treatment of MRSA. FDA conducts research focused in identifying potential vaccine components that can protect against various forms of MRSA 

disease and on developing animal models that can be used to evaluate the protective 

capabilities of these vaccines. 

In addition, FDA has cleared more than ten diagnostic tests for detection or 

screening for MRSA. We continue to actively work with industry as they develop 

their devices to assure that safe and effective devices to detect MRSA are cleared 

through FDA in an expedient manner. We are also actively involved with clinicians, 

laboratory experts, and governmental agencies to determine changes in antibiotic 

resistance and determine what testing is necessary to detect changes in resistance. 

Question. Is funding provided in the budget for FDA to test for the presence of 

MRSA in the swine herd? Is this an appropriate activity for FDA to undertake? 

Answer. Although the fiscal year 2010 budget does not include specific funding 

to test for the presence of MRSA in the swine herd, FDA agrees that MRSA needs 

to be studied. FDA is working closely with USDA and CDC to address issues relating to the prevalence of MRSA. 

FDA is in the midst of a pilot study that is testing retail meat samples for MRSA 

and will use the results of this study to determine the correlation, if any, to clinical 

cases of infection. 

OFFICE OF COSMETICS AND COLORS

Question. Please provide a history of the budget authority funding amounts for 

the Office of Cosmetics and Colors for the past 5 years. 

Answer. The 5-year budget authority funding history for the Office of Cosmetics 

and Colors (OCAC) cosmetics program and the companion program in FDA’s field 

component, the Office of Regulatory Affairs (ORA), appears in the following chart. 

OCAC current cosmetics activities include developing regulations, guidance, and policy, providing direction to the field program, conducting safety assessments, administering the Voluntary Cosmetic Registration Program (VCRP), and participating in 

international harmonization activities. During fiscal year 2007, CFSAN centralized 

all cosmetics compliance and research components into offices outside OCAC, with 

one office focused entirely on compliance and a second office focused entirely on research. Compliance and research staff from OCAC were realigned to these offices 
31 

and are reflected under the column titled ‘‘Other CFSAN Cosmetics FTEs’’ in the 

following table. OCAC also has a color certification program, which is exclusively 

supported by user fees and not supported by appropriated funds. We estimate that 

the color certification program will collect $7.7 million in fiscal year 2009. 

The ORA activities in the field cosmetics program include inspections and field 

exams, sample analyses for contaminants and non-permitted ingredients, and evaluations for labeling compliance. 

COSMETICS PROGRAM FIVE YEAR FUNDING HISTORY 

Fiscal Year 

CFSAN ORA Total 

Dollars in millions OCAC Cosmetics FTEs 

Other CFSAN 

Cosmetics 

FTEs 

Dollars in millions FTE Dollars in millions FTE 

2005 .................. $3.4 28 ( 1 ) $1.8 14 $5.1 42 

2006 .................. 3.4 27 ( 1 ) 1.7 12 5.1 39 

2007 .................. 2.3 10 7 1.9 13 4.2 30 

2008 .................. 3.8 13 8 2.3 14 6.1 35 

2009 .................. 5.0 15 8 2.9 15 7.9 37 

1 Not available.

Question. Is the funding level in the President’s budget adequate? 

Answer. The fiscal year 2010 President’s Budget provides $8,204,000 for the FDA 

cosmetics program. As in other product areas that FDA regulates, changes in technology and the increasingly global nature of the industry present challenges to FDA 

regulation of the cosmetics industry. FDA will continue to assess the risks to public 

health of cosmetic products and [the administration will] seek additional resources 

where necessary. 

DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE AVAILABILITY

Question. How much of the funding provided in fiscal year 2009 has been obligated? 

Answer. Fiscal year 2009 is the first year of the Pediatric Device Grants Program. 

As of May 2009, none of the $2 million appropriated for pediatric device consortia 

grants has been obligated. The due date for grant applications is June 15. FDA 

plans to make grant awards by September 30, 2009. 

Question. How many applications were received for this program, and what was 

the total? 

Answer. We will know how many applications we received after the June 15 closing date for program applications. Based on inquiries from potential applicants, we 

expect to receive at least six applications. 

Question. Of the total applications received, how many were funded? 

Answer. Pediatric Device grants will be awarded on a competitive basis. FDA will 

review the grant applications scored by a panel of experts in mid-July. Shortly 

thereafter, we will know how many are funded. 

Question. What types of activities are these grants funding? 

Answer. Once FDA makes grant awards in September, we will be happy to provide you with more specific information on the activities funded. The goal of this 

grants program is to promote pediatric device development by providing grants to 

nonprofit consortia. The consortia will facilitate the development, production, and 

distribution of pediatric medical devices by encouraging innovation, mentoring and 

managing pediatric device projects, and providing assistance and advice to 

innovators and physicians on business development. 

COST OF INSPECTIONS

Question. What is the average cost of a foreign and domestic food inspection and 

medical product inspection? 

Answer. FDA estimates the average total cost for a domestic food inspection 

would be $9,700 and $24,400 for a foreign food inspection in fiscal year 2010. We 

also estimate the average total cost for a domestic medical product inspection would 

be $20,300 and $41,900 for a foreign medical product inspection in fiscal year 2010. 

The inspection cost figures include inspectional time, compliance review, supervisory 

oversight, and general administrative costs for all applicable FDA offices. 

The numbers of hours FDA investigators spend on a food or medical product inspection can vary from just a few hours to well over 100 hours due to the different 

types of products, manufacturing processes and numbers of quality systems to cover 
32 

during any one inspection. Food inspections include, but are not limited to, food 

safety, low acid canned foods, acidified foods, seafood HACCP, and interstate travel 

sanitation. Medical product inspections include, but are not limited to, pre-approval 

and pre-market inspections of medical devices and human/animal drugs, bioresearch 

monitoring inspections for biologics, medical devices, and human/animal drugs, 

blood banks, donor centers, source plasma, human tissue processors, post-market 

GMP surveillance for biologics, drugs and devices, medical gas, radiological health, 

and adverse drug events. 

The figures above do not include the costs to the agency to collect and test a sample of a product or to conduct any actions that may result from problems the agency 

identifies during an inspection, such as a recall or a follow up inspection to see that 

appropriate actions were taken to correct a violation. 

CRITICAL PATH

Question. Please provide a list of all projects funded through the Critical Path Initiative, and their amounts, in fiscal year 2009. 

Answer. I am providing a complete list of all Critical Path (CP) projects that received FDA support during fiscal year 2009. So far, 98 specific projects received approximately $34,675,000 of support, including $16 million specifically designated to 

support CP projects. The list reflects the breadth and depth of the Critical Path Initiative and also underscores our need to continue funding this important Initiative. 

In addition, almost $12 million of the 2009 total of $34,675,000 supported the Sentinel Initiative, a long-term effort to increase medical product safety. Sentinel will 

fulfill some of the requirements of section 905 of FDAAA and enable FDA to build 

a system to actively monitor the safety and efficacy of FDA-regulated products. 

FERN LABS

Question. Please provide a list and description of all of the FERN labs. 

Answer. I would be happy to provide that for the record. 

States 

Chemistry Cooperative Agreement Labs: 

Arizona Department of Health Services ...................................................................................................... AZ 

Arkansas Department of Health ................................................................................................................. AR 

California Animal Health & Food Safety—CAHFS ...................................................................................... CA 

California Department of Public Health, Food and Drug Laboratory Branch ............................................ CA 

Colorado Department of Public Health ....................................................................................................... CO 

Commonwealth of Virginia Division of Consolidated Laboratory Services ................................................. VA 

Connecticut Agricultural Experiment Station .............................................................................................. CT 

Consumer Analytical Laboratory Ohio Department of Agriculture .............................................................. OH 

Florida Department of Agriculture and Consumer Services ....................................................................... FL 

Minnesota Department of Agriculture ......................................................................................................... MN 

Nebraska Department of Agriculture .......................................................................................................... NE 

New Hampshire Public Health Laboratories ............................................................................................... NH 

University Hygienic Laboratory—Iowa ........................................................................................................ IA 

Wisconsin Department of Agriculture ......................................................................................................... WI 

Radiological Cooperative Agreement Labs: 

Maryland Department of Health and Mental Hygiene ................................................................................ MD 

Health Research/NY Department of Health ................................................................................................ NY 

Texas Department of State Health Services Laboratory ............................................................................. TX 

Washington State Public Health Laboratory ............................................................................................... WA 

Wisconsin State Laboratory of Hygiene ...................................................................................................... WI 

Question. Are these labs utilized when there is a food safety outbreak? How? 

Answer. Yes, FDA has used FERN labs to support several recent food safety outbreak investigations. FDA-funded FERN Chemistry labs analyzed more than 200 

samples of protein products for the presence of melamine in 2007. These samples 

were supplied to the FERN labs by an FDA Protein Surveillance assignment written 

specifically for the FERN chemistry labs. In 2008, FERN chemistry laboratories 

tested for melamine contamination of milk products. FERN labs tested nearly 300 

samples to clear the FDA lab backlog of samples. 

FDA also collaborates with other FERN labs that are not receiving FDA funding 

to respond to food safety outbreaks. In 2006, FERN laboratories provided support 

to State labs for the E. coli O157:H7 Spinach outbreak. A rapid FERN method was 

provided to State labs, as well as reagents to support the method. Labs were used 

to test suspect foods. Last summer, FERN laboratories tested 290 samples for Sal-
33 

monella during the jalapeno peppers outbreak. These samples were provided to the 

FERN labs through an FDA assignment. This year, FERN laboratories provided test 

results to FDA to assist product tracking in the Salmonella in peanut butter outbreak. This rapid reporting of State sample results had a significant impact on the 

investigation of this outbreak. 

Question. FDA’s belief that FERN labs are underutilized? What additional roles 

could or should they play? 

Answer. FDA is continuing to develop the role of FERN labs to respond to food 

safety outbreaks. Throughout the year, FERN laboratories participate in a variety 

of activities, including but not limited to training to build capability, proficiency 

testing to assess individual lab capability, and collaboration on current methods and 

equipment use. In addition, FDA used FERN laboratories to analyze samples during 

large-scale surveillance assignments or during public health emergencies. Specifically in 2008, FERN chemistry cooperative agreement laboratories played an important role in the FDA response to melamine contamination by analyzing more than 

300 milk-related food samples for the presence of melamine. 

QUESTIONS SUBMITTED BY SENATOR DIANNE FEINSTEIN

COSMETIC SAFETY

Question. I am particularly interested in your agency’s ability to ensure that personal care products and food and drink packaging do not contain dangerous chemicals. Most Americans think the FDA regulates cosmetics the same way it regulates 

food and drugs. However, the reality is that the $50 billion cosmetics industry is 

one of the least regulated industries in the country. 

Under current law, cosmetics companies may use unlimited amounts of virtually 

any ingredient, including chemicals linked to cancer, reproductive and developmental harm, hormone disruption and other adverse health impacts, with no premarket safety assessment. The FDA does not have the authority to require product 

recalls and must go to court to remove misbranded and adulterated products from 

the market. The FDA also lacks the authority to require manufacturers to register 

their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. As a result, cosmetics sold in the United States contain ingredients and impurities with known health hazards including lead, mercury, hydroquinone, coal tar, 

formaldehyde, 1,4-dioxane, acrylamide, toluene and phthalates. 

Given this situation, would you support efforts to give FDA the authority, resources and staff it needs to ensure that cosmetics and their ingredients are substantiated for safety before they are marketed to consumers? 

Answer. The Administration has not taken a position on giving FDA additional 

authority and resources for the regulation of cosmetics. However, we would be 

happy to work with you and other Members of Congress on legislative proposals 

that offer additional public health protection for consumers. 

Question. Can you tell me the staff size and current fiscal year budget of the Office of Cosmetics and Colors? 

Answer. The Office of Cosmetics and Colors (OCAC) has two major components, 

each responsible for a different program. The OCAC Color Certification Program is 

staffed with 32 FTEs and is supported exclusively by user fees, not by appropriated 

funds. We estimate that the Color Certification Program will collect $7.7 million in 

fiscal year 2009. The total fiscal year 2009 budget for the OCAC Cosmetics Program 

is approximately $5.0 million. This amount supports 15 FTEs and includes $1.6 million in operating funds. Finally, in fiscal year 2009, FDA’s ORA has been allocated 

a budget of $2,866,500 and approximately 15 FTEs for its activities in support of 

the cosmetics program. 

Question. In October of 2007, the Campaign for Safe Cosmetics, a coalition of public health advocates, released a report showing that 61 percent of the lipsticks tested 

contained lead. In November of 2007, I joined my colleagues Senators John Kerry 

and Barbara Boxer in requesting that the FDA test a variety of lipsticks for lead, 

release the testing results publically, and if lead is found, take immediate steps to 

reduce the level of lead in these cosmetics. Despite numerous requests, we have not 

been informed of the results of any testing. Has that testing been completed, and 

if so, will you release the results in a timely and publically accessible format? 

Answer. FDA scientists developed and validated a highly sensitive method to analyze total lead content in lipstick. FDA applied the new method to the same selection of lipsticks evaluated by the Campaign for Safe Cosmetics. The results of FDA’s 

work to develop this method and conduct initial testing have been accepted for pub-
34 

lication in the peer-reviewed Journal of Cosmetic Science and will be published in 

the July/August 2009 issue. We will also be posting information on our website. 

Although FDA found lead in all of the lipsticks tested, the levels detected were 

within the range that would be expected from lipsticks formulated with permitted 

color additives and other ingredients prepared under good manufacturing practice 

conditions. FDA does not believe the lead levels we have found in our testing represent a safety concern. Nevertheless, FDA will continue to monitor the situation. 

We are also planning a broad-based survey that will examine a wider range of lipsticks than has been tested so far. When that testing is complete, FDA will make 

the results publicly available. If, at any time, FDA determines that a safety concern 

for lead in lipstick exists, FDA will advise the industry and the public and will take 

appropriate action under the authority of the Federal Food, Drug, and Cosmetic— 

FD&C—Act to protect the health and welfare of consumers. 

Question. Under current law, registering cosmetics manufacturing facilities with 

the FDA is voluntary, even though this process would allow the FDA to better understand the breadth of the industry it is charged with regulating. A GAO study 

submitted to Congress in 1990 estimated that about 40 percent of facilities had in 

fact registered. What is the current estimate of the number of manufacturing facilities creating products for sale in the United States? What percentage of those facilities has registered with the FDA? How many inspections of cosmetics manufacturing facilities were conducted by the FDA in the last fiscal year? 

Answer. Information provided by the two primary U.S. cosmetic trade associations 

indicates that there are approximately 3,500 cosmetic manufacturing facilities in 

the U.S. associated with their organizations. FDA does not have independent data 

to confirm that estimate. In addition to manufacturing facilities that are members 

of the two primary cosmetic trade associations, there also are facilities that are not 

members of either of the associations. Consequently, it is very difficult to say with 

any degree of certainty how many cosmetic manufacturing facilities there are in operation in the United States at any given time. There are 761 cosmetic manufacturing facilities registered in FDA’s Voluntary Cosmetic Registration Program 

(VCRP). If the estimate of 3,500 cosmetic manufacturing facilities covered all U.S. 

manufacturing facilities, the VCRP data would indicate a registration rate of 22 percent. The actual registration rate is likely lower. In fiscal year 2008, FDA conducted 

88 inspections of domestic cosmetic manufacturing facilities. 

Question. The safety of chemicals used in cosmetics is not determined by the FDA, 

but rather a voluntary process conducted by an industry funded panel—the Cosmetics Ingredients Review—CIR—Program. In over 3 decades since its creation, CIR 

has evaluated only 11 percent of the 12,500 ingredients used in cosmetics; the vast 

majority of ingredients have not been assessed for safety by FDA, CIR or any other 

publicly accountable body. At the CIR, ‘‘insufficient data’’ to assure safety is not considered a rationale for recommending restricted use of a chemical. Does any other 

FDA program allow lack of evidence to be construed as proof of safety? Does the 

FDA have a plan for generating safety studies on unstudied chemicals used in cosmetics? 

Answer. While there are approximately 15,500 cosmetic ingredients listed in the 

International Cosmetic Ingredient Dictionary and Handbook, many of these are not 

commonly used in cosmetics in the United States today. FDA estimates that approximately one third of the products on the U.S. market are filed in FDA’s Voluntary Cosmetic Registration Program (VCRP) database. The VCRP data indicate 

approximately 3,200 ingredients that are each listed in at least 10 products. These 

3,200 ingredients represent a high percentage of the ingredients used in marketed 

cosmetics. The Cosmetics Ingredients Review (CIR) Program has reviewed the safety of more than 1,400 ingredients. Because ingredients are selected for review based 

in part on their frequency of use, many of the commonly used ingredients have been 

evaluated by the CIR. Many of the less common ingredients have also been evaluated by the CIR. 

Under the law, cosmetic products and ingredients—except color additives—are not 

subject to FDA pre-market approval. For FDA to prohibit use of a particular cosmetic ingredient or limit the conditions in which it can be used because the ingredient is adulterated requires scientific evidence establishing that the substance is 

harmful under its conditions of use or evidence that it is adulterated for other reasons. FDA cannot prohibit the use of an ingredient based solely on a CIR conclusion 

that there are insufficient data to establish its safety. The burden of proof rests with 

FDA to demonstrate that an ingredient is adulterated because it is unsafe or for 

other reasons before it can be prohibited. 

FDA uses resources available to the cosmetics program to evaluate the safety of 

cosmetic products and ingredients when a possible human health risk is indicated. 

FDA evaluates data and information from a variety of sources. The sources that 
35 

FDA relies on include: adverse event reports, FDA’s laboratory research, other published scientific literature, information considered and conclusions reached by the 

CIR Expert Panel, and data and other information provided to FDA by a variety 

of stakeholders. FDA’s evaluations include consideration of routes of exposure and 

possible vulnerable populations. 

Question. In 1989, the FDA prioritized 130 chemicals for review out of 884 chemicals that were both listed in the Registry of Toxic Effects of Chemical Substances 

and could be used in cosmetics. Of those 130 highest-priority chemicals, how many 

has the FDA substantiated for safety? How many has the CIR assessed? Has the 

FDA requested and reviewed the safety data from CIR’s safety assessments? Of 

those 130 chemicals, how many have been restricted or banned from use? 

Answer. We were not able to locate any FDA documents that match the description you provided of a list of 130 chemicals prioritized for review. In the absence 

of such a document or a list of specific chemicals to which your questions pertain, 

we cannot provide numerical answers to the questions posed. We can only provide 

some general information. 

FDA does not substantiate the safety of cosmetic ingredients. It is the responsibility of the cosmetic manufacturer or distributor that introduces a cosmetic product 

into the marketplace to substantiate the safety of the finished product and its ingredients before it markets the cosmetic product. FDA does, however, investigate and 

evaluate ingredient safety when we receive reports of adverse events, become aware 

of results from scientific studies that indicate a potential for harm to consumers, 

or receive other information that raises questions about safety. FDA’s safety assessments incorporate data and information from a variety of sources and include consideration of routes of exposure and possible vulnerable populations. 

FDA participates in the CIR review process as a liaison member with non-voting 

status. As a participant, we receive and review the same information as the voting 

members of the Expert Panel. We also have the opportunity to comment on the 

studies at the open CIR meetings. 

Question. I am also very concerned about the continued use of Bisphenol A in food 

and beverage packing. As you know, this chemical has been linked to a variety of 

health problems, including breast cancer, prostate cancer, and altered brain development. What is your time table for re-reviewing the safety assessment of BPA that 

FDA staff presented to the Science Advisory Board in October 2008? 

Answer. In the fall of 2008, FDA scientists presented to the Science Board a draft 

safety assessment of the use of Bisphenol A—BPA—in the manufacture of food contact materials. The Science Board raised questions about whether the FDA’s review 

had adequately considered the most recent available scientific literature. We have 

been carefully considering the Science Board comments, as well as reviewing newly 

available publications. During the summer of 2009, FDA scientists will review the 

science of BPA. We intend to report on the findings of this review in late summer 

or early fall of this year. 

Question. On May 16, 2009, the Milwaukee Journal Sentinel described repeated 

contacts between Bisphenol A industry officials and FDA staff. As the FDA reviews 

the science on the risks of BPA, how will you ensure that FDA staff working on 

the safety assessment does not further coordinate their research with the chemical 

industry? Do you plan to take steps to provide independent scientists with equal access to FDA officials? 

Answer. Independent scientists have already met several times with FDA officials 

in the last several months on BPA. The current review of BPA will benefit from 

input from a variety of sources and the best available scientific evidence. 

Question. What is your assessment of the current process FDA uses to determine 

the safety of food additives in packaging? How could this process be improved prospectively? Considering the current list of approved additives includes chemicals 

such as phthalates, mercury, and formaldehyde, does the FDA have any plans to 

reevaluate the list? 

Answer. By law, food additives in packaging must be approved for their use prior 

to marketing. This requirement, which has been in existence since 1958, has provided a very high standard of consumer protection, and is one of the most rigorous 

statutory and regulatory schemes for authorizing food packaging materials in the 

world. 

It is true that scientific information and knowledge are constantly evolving. We 

do monitor the scientific literature and undertake re-reviews of additives based on 

emerging data and information. We are committed to improving and modernizing 

our ability to adequately monitor the world-wide literature on the many thousands 

of compounds that are used in food contact applications, so that we can make appropriate decisions in as timely a way as possible. 
36 

Question. A New York Times article that appeared on May 15 entitled ‘‘For Frozen Entrees, ‘‘eat and Eat’’ ‘‘Isn’t Enough,’’ explains that frozen food, such as Pot 

Pies, require additional cooking and testing on the part of the consumer before they 

are considered safe to eat. I am very concerned about placing the burden of assuring 

food safety on consumers, many of whom purchase these products for convenience 

and with the belief that they are safe to eat. Does the Food and Drug Administration allow frozen entrees such as Pot Pies to contain harmful pathogens at the time 

of purchase by the consumer? 

Answer. Ordinarily, FDA considers a frozen entre ́e to be a ‘‘ready-to-eat’’ food that 

may not contain pathogens at the time of purchase by the consumer, irrespective 

of whether the product label includes cooking instructions, because some consumers 

eat such foods without thorough cooking. According to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. § 342(a)(1), a food is deemed to be adulterated if it contains any poisonous or deleterious substance—such as a pathogen— 

that may render it injurious to health. The law prohibits introduction of adulterated 

food into interstate commerce, and FDA consider regulatory action on a case by case 

basis. 

Question. What steps does the FDA take to make sure that producers reduce or 

eliminate the presence of pathogens in frozen entrees? 

Answer. FDA has established current Good Manufacturing Practice—cGMP—in 

Manufacturing, Packing, or Holding Human Food regulations—21 CFR part 110, 

which require that food is processed under safe and sanitary conditions. The regulation, 21 CFR 110.80(a)(2), specifically requires that ‘‘Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated 

during manufacturing operations so that they no longer contain levels that would 

cause the product to be adulterated within the meaning of the act. Compliance with 

this requirement may be verified by any effective means, including purchasing raw 

materials and other ingredients under a supplier’s guarantee or certification.’’ In addition, 21 CFR 110.80 States ‘‘All reasonable precautions shall be taken to ensure 

that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination.’’ These two provisions are designed to prevent, reduce, or eliminate the presence of pathogens in 

food. 

Question. Does the FDA currently conduct inspections of food labels for frozen 

entrees that contain raw or uncooked ingredients, to ensure that the labels clearly 

indicate that the foods may contain pathogens without proper preparation? 

Answer. There is currently no requirement for this type of statement for FDA-regulated foods. FDA inspection instructions do not address the presence of this type 

of statement. 

Question. As you know, the Food and Drug Administration announced in March 

2009 that some patients with ALS to would be allowed to access the drug Iplex 

under an Investigational Drug Application—IND. Because this disease can progress 

rapidly, timely access to treatments may potentially make a difference in a patient’s 

outcome. Since the FDA’s announcement in March, what progress has been made 

on beginning a clinical trial of the drug, or establishing a lottery system to give patients access to a clinical trial? 

Answer. FDA continues to work proactively with the sponsor, Insmed, on the development and initiation of a well-designed clinical trial of Iplex in ALS patients. 

Question. When do you anticipate that FDA will grant final approval for a clinical 

trial to begin? 

Answer. When an investigational new drug application, or IND, is submitted, 

FDA has a maximum of 30 days to determine if the protocol may proceed. However, 

after this period of review, it is entirely up to the sponsor when to initiate the clinical trial. 

Question. How many patients will ultimately be able to enroll in the clinical trial? 

Answer. It is not known at this time how large the clinical trial would be, because 

the number of patients that can be enrolled in it is directly related to the length 

of the trial proposed and the existing supply of the drug at the time the trial begins. 

Insmed, the sponsor, has indicated that the supply of this drug is very limited. 
37 

QUESTION SUBMITTED BY SENATOR RICHARD J. DURBIN

GAO

Question. In January 2009, GAO released a report recommending that FDA take 

further actions to improve oversight and consumer understanding of dietary supplements. Two of GAO’s recommendations called for FDA to issue guidance: first to 

clarify when an ingredient is considered a new dietary ingredient, the evidence 

needed to document the safety of new dietary ingredients, and appropriate methods 

for establishing ingredient identity; and second, to clarify when products should be 

marketed as either dietary supplements or food. Does FDA plan to issue guidance 

to address these recommendations? 

Answer. FDA agrees that guidance would be helpful to clarify when an ingredient 

is considered a new dietary ingredient (NDI) the evidence needed to document the 

safety of NDIs, and appropriate methods for establishing the identity of an NDI. 

The Agency held a public meeting in November 2004 to seek public comment on several issues related to the NDI requirements of Section 413(a)(2) of the Federal, 

Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(2)). FDA specifically asked for information that would enable the Agency to identify ways to assist submitters of NDI 

notifications to ensure that they contain the information the Agency needs to evaluate the notification. FDA has reviewed the information submitted by interested parties on this subject and has developed draft guidance addressing NDI issues and a 

draft proposed rule to amend the NDI notification requirements of the Federal Food, 

Drug, and Cosmetic Act. The guidance and proposed rule are currently undergoing 

internal FDA review. 

As we noted in our comment to the GAO July 2000 report, FDA’s Dietary Supplement Strategic Plan recognized the need to clarify the boundaries between dietary 

supplements and conventional foods, including conventional foods with added dietary ingredients. As we noted when the Plan was released in January 2000, FDA 

acknowledged its inability to set timeframes for all the activities listed in the Plan 

because of resource limits. FDA will consider this recommendation and the priority 

and timing to implement this recommendation in light of all of the priorities that 

compete for available resources. 

QUESTIONS SUBMITTED BY SENATOR SAM BROWNBACK

TUBERCULOSIS: DRUG RESISTANT TB AND DIAGNOSTIC TESTS FOR CHILDREN

Question. The subcommittee has provided more than $23 million in the past 2 

years to support the Critical Path Initiative, an FDA initiative that has many facets 

including helping speed the development of safe drugs and the development of diagnostic tests to help with the delivery of drugs or diagnose certain conditions. 

As you may know, I am concerned about global health problems, especially the 

growing threat of Tuberculosis and drug resistant Tuberculosis. The first recommendation in an Institute of Medicine November 2008 White Paper on drug resistant TB is for in-country diagnostic tests, including rapid genetic tests able to diagnose drug resistant organisms. 

The need for improved diagnostic tests and effective therapies is even more critical for children with TB. The standard tests for diagnosis of TB, sputum smears 

and culture, are not practical for children who cannot reliably produce sputum. As 

a result they remain undiagnosed, untreated and a source of infection for others. 

The Critical Path Initiative seems like a logical fit for FDA to help with this situation. 

Does FDA currently have any critical path projects that address the threat of Tuberculosis and drug resistant TB? 

Answer. Yes, the Critical Path Initiative—CPI—is working to advance the use of 

multi-drug resistant TB as a platform for demonstrating effectiveness of new TB 

drugs. This is a novel approach for tackling the scientific challenge of proving drug 

effectiveness when you have a complex treatment regimen, requiring new TB drugs 

to be tested in combination with older drugs. 

CPI has begun exploring possible collaborations with several goals in mind. For 

example, FDA is hoping to collaborate on identifying novel scientific pathways for 

obtaining safety data on new TB drugs without co-administration with other drugs. 

One option might be to obtain safety data on a new TB drug during use in prevention trials. 

FDA is also exploring possible collaborations with the Bill Gates Foundation that 

will facilitate TB drug and diagnostic development by creating innovative trial designs and trial logistics. The goal is to develop shorter treatment regimens and new 
38 

diagnostic tools that can be used in all patients, including children. FDA has developed the CPI biomarker qualification process as a mechanism for incorporating new 

diagnostics in clinical trials. And to facilitate international marketing application 

and approval, FDA is collaborating with the European Medicines Agency to reach 

similar regulatory recommendations on drug development in multi-drug resistant 

TB. 

Question. Would additional funding for critical path programs make it possible to 

work with the industry to accelerate the development of new and more effective 

drugs or diagnostic tests for TB? 

Answer. If FDA received increased resources for critical path activities related to 

tuberculosis, we would consider beginning large-scale training program that would 

give local public health staff in developing countries the capabilities they need to 

develop and submit sufficient, high-quality scientific data to FDA to support application evaluation and approval. Other options include bringing together collaborative 

initiatives among drug, vaccine, and diagnostic developers and other experts in the 

field to speed development of new therapies in all populations and subpopulations. 

This effort is especially critical because development of new diagnostic tests is growing at a tremendous pace now. Preliminary test results using new genomic methods 

to identify drug resistant TB are very promising, and these need to be tested in 

large populations so they can be incorporated into clinical trials and clinical practice. Rapid, reliable tests that can easily be used to diagnose tuberculosis in adults 

and children are also required. The development of these products depends on access to communities where TB is common and where high-quality studies can be 

performed. 

The Bill Gates Foundation and World Health Organization are heavily involved 

in this area, and FDA is actively encouraging manufacturers to participate. Additional Critical Path funding could be used to foster collaborations with all stakeholders with the goal of moving TB diagnostic tests to market faster. 

POLICY PROPOSALS: DRUG IMPORTATION AND GENERIC BIOLOGICS

Question. The President plans to propose two new policy changes for FDA. One 

will allow the importation of prescription drugs from foreign countries. The second 

will allow FDA to approve generic biologics. The budget requests $5 million for the 

development of policies associated with prescription drug importation. Very few details have been provided about these policy proposals or to support the funding request related to the drug importation policy. Can you provide any additional details 

on these proposals? 

Answer. Regarding details related to drug importation, the fiscal year 2010 budget includes $5 million for FDA efforts to allow Americans to buy safe and effective 

drugs approved in other countries. FDA intends to spend these funds in fiscal year 

2010 to assess the feasibility, practicability, and implementation needs of a drug importation program. 

The fiscal year 2010 Budget supports the creation of a new regulatory pathway 

under the Public Health Service Act for FDA approval of ‘‘generic biologics,’’ a term 

that refers to follow-on biological products that are highly similar to—or biosimilar—and may be substitutable or interchangeable for a previously approved biological product. As I mentioned in my testimony, establishing a generic biologics 

pathway will require new legislation. 

FDA has approved follow-on versions of certain protein products under the existing abbreviated approval pathways in the Federal Food, Drug, and Cosmetic Act. 

However, the majority of protein products now on the market have been licensed 

as biological products under the Public Health Service Act, which does not contain 

analogous abbreviated approval pathways. 

Safe and effective generic biologics may prove to be a critical element to lowering 

costs for American consumers and the healthcare system more broadly. FDA would 

require additional resources to augment our existing capabilities for regulatory activities associated with a generic biologics program, and anticipates the need for significant additional analytical testing capabilities. Depending on the scope and requirements of any legislation establishing a generic biologics pathway, we expect 

that there will be a large workload in the early phase of a generic biologics program 

in our pre-application activities—including meeting with industry and providing advice—as well as developing policy and procedures, publishing guidance, and promulgating regulations. We also anticipate receiving some applications for review shortly 

after enactment of legislation, with an increasing number of applications for review 

in subsequent years. 

Question. Given that these proposals are being associated with reduced health 

care costs for Americans, do you believe that these will be included in the Presi-
39 

dent’s health care reform proposal? Are the policies developed enough at this time 

to be considered as a part of the health care debate? 

Answer. Regarding drug importation, the fiscal year 2010 budget request is intended to conduct assessments to determine the feasibility, practicability, and implementation needs of a drug importation program. 

Regarding generic biologics, the fiscal year 2010 Budget supports the creation of 

a new regulatory pathway under the Public Health Service Act for approval of generic biologics. Safe and effective generic biologics may prove to be a critical element 

to lowering costs for American consumers and the healthcare system more broadly. 

Question. Let’s say both proposals are passed this year, does the fiscal year 2010 

request provide appropriate resources to enact the new policies? 

Answer. Regarding drug importation, the fiscal year 2010 request is not intended 

to provide resources to enact any new policy. Rather, the budget request is intended 

to determine whether and what programs might be feasible, practical, and what 

would be needed for implementation. 

Regarding generic biologics, the fiscal year 2010 request is not intended to provide 

resources to enact a new policy on generic biologics, given that creation of a generic 

biologics pathway would require new legislation. Although the administration budget proposal describes user fees as a financing structure to cover certain costs of a 

new generic biologics pathway, the current proposal indicates that precise collection 

levels would be negotiated for each year, including fiscal year 2010. 

PERFORMANCE RESULTS

Question. We have made significant investments in FDA. Since 2006, FDA’s appropriation has increased by 39 percent. If the fiscal year 2010 budget is enacted 

as requested, FDA’s appropriation will have increased by 59 percent in 4 years. This 

is a significant amount of money and we expect FDA to be accountable for these 

resources and show results. What is your plan for showing tangible outcomes for 

the resources we have made available? 

Answer. FDA’s plan for showing tangible outcomes for the resources Congress has 

made available is to track our progress toward specific milestones and report our 

accomplishments to Congress on a regular basis. FDA is reporting accomplishments 

on a monthly basis for its expenditures of fiscal year 2008 Supplemental funding. 

For expenditures of the funding increases FDA received in the fiscal year 2009 Omnibus bill, we report accomplishments on a quarterly basis. 

Question. I expect that FDA’s goals will be something to strive for and not something that can be easily attained, do you share this expectation? 

Answer. Where our goals are specific, FDA should meet them or have a good explanation for failing to do so. Where our goals are aspirational, FDA should be able 

to demonstrate concrete progress towards improving the health of the American people. 

TOBACCO REGULATION

Question. Congress is likely to pass a bill this year that will give FDA authority 

to regulate tobacco. The administration supports this effort. We’ve mentioned that 

FDA currently regulates 20 percent of all consumer expenditures. Adding more to 

this already daunting job is not an easy task. 

The authorizing committee has tried to make sure that industry user fees, and 

not appropriated dollars, are used to support tobacco regulation. However, until the 

fee is collected, which could be months after enactment of the tobacco bill, FDA will 

be permitted to use appropriated funding to start the process of regulating tobacco. 

The Appropriations Committee has provided funding for very specific food safety 

and medical product safety activities. We do not want to see these efforts unnecessarily delayed because FDA shifts its focus to tobacco. 

What assurance can you give me that any appropriated funding directed to tobacco will not delay critical activities we have funded? What is the minimum 

amount of appropriated dollars necessary to get the tobacco user fee program started? 

Answer. In order to begin implementation of this important program FDA will 

borrow $5 million from its fiscal year 2009 budget authority. This modest sum is 

necessary to establish a process to calculate the amount of user fees due, issue bills, 

and collect fees from covered manufacturers and importers of tobacco products. We 

estimate that we will need approximately 4 staff to establish the user fee program 

and there will be associated expenses to adapt our existing IT systems to include 

billing and collection of these fees. In addition to establishing the user fee program, 

we would also use these borrowed funds to hire a small number of staff, perhaps 

10 or 12 individuals, to begin the work entrusted to the new Center for Tobacco 
40 

Products. The agency would repay the borrowed funds within 6 months or as soon 

as sufficient user fees are collected. We have identified sources for these funds 

where borrowing and repaying the funding will not affect other FDA activities. 

After this initial start up period, 100 percent of FDA activities related to tobacco 

will be funded through the collection of user fees from the tobacco industry. 

Question. FDA has a limited leadership team that’s currently struggling to keep 

up with the agency’s current mission. How do you intend to make sure that tobacco 

regulation does not hinder this leadership team’s ability to work on food safety and 

medical product safety issues? 

Answer. The creation of this center will not distract the agency from its other activities and or hinder its ability to work to improve the safety of food and medical 

products. The agency is working to recruit a strong director for the Center for Tobacco Products who will have our full support in implementing the Family Smoking 

Prevention and Tobacco Control Act. After the initial start up period, 100 percent 

of FDA activities related to tobacco will be funded through the collection of user fees 

from the tobacco industry. 

FOOD SAFETY, WHITE HOUSE WORKING GROUP

Question. As a member of the White House Food Safety Working Group, what priorities have you outlined regarding food borne pathogens? 

Answer. From E. coli O157:H7 in spinach to Salmonella in peanut butter, foodborne pathogens are the most significant cause of food borne illness outbreaks. In 

the White House Food Safety Working Group, or WHFSWG, FDA has advocated for 

requirements for wide scale adoption of preventive controls by the food industry, in 

addition to supporting specific actions to reduce food borne pathogens such as Salmonella Enteritidis in shell eggs and E. coli O157:H7 in leafy greens. Effective preventive controls can reduce or eliminate foodborne pathogens. FDA has also suggested an enhanced public health surveillance infrastructure to help determine a 

baseline for pathogens of public health significance in foods, determine the source 

and respond more quickly when pathogens appear to be linked to foodborne illness, 

and prioritize the development and use of rapid detection methods for foodborne 

pathogens. In addition, FDA has recognized the agency’s need to provide better information to consumers on the steps they can take to minimize these hazards, including thorough cleaning and cooking of foods and appropriate handling practices 

to reduce the likelihood of cross contamination. 

Question. There has been discussion that there should be on-farm testing of livestock for food borne pathogens; is this something you support and if so could you 

elaborate? 

Answer. Foodborne pathogens in livestock create at least two potential issues: 

contamination of the meat or other products from livestock and contamination of 

crops when the pathogens are spread through the waste of the livestock. USDA has 

preventive control programs in slaughterhouses to address the first issue. The second issue requires study of the microbial ecology of the farm environment, and 

standards for the safe production of produce. It is premature to say whether testing 

would be the most effective approach at this point. 

USE OF ANTIBIOTICS IN ANIMALS

Question. Antibiotics have been used to treat and prevent disease or promote 

growth in animals for more than 50 years. Like physicians and their patients, veterinarians and their clients share responsibility for the proper use of antibiotics. 

Antibiotics are tools used by veterinarians and producers to quickly address clinical 

and sub-clinical disease and keep animals healthy and productive. Antibiotics used 

by producers are approved by the FDA after they undergo rigorous review for safety 

to animals, humans and the environment. Producers have a vested interest in using 

antibiotics responsibly and view the use of antibiotics very seriously, yet there are 

attempts by some to eliminate antibiotic use on the farm. Animals get sick. Our producers and veterinarians need the tools to keep them healthy. What do you plan 

to do with the animal antibiotic approval process? 

Answer. In 2003, FDA implemented new policies for evaluating antimicrobial drug 

safety as part of the new animal drug approval process. At that time, FDA issued 

Guidance for Industry—GFI—#152, Evaluating the Safety of Antimicrobial New 

Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human 

Health Concern. This guidance describes a risk-based assessment process for evaluating antimicrobial resistance concerns associated with the use of antimicrobial new 

animal drugs in food-producing animals. The guidance also describes recommended 

measures for mitigating such risk. FDA believes the assessment process described 

in this guidance has been a very effective approach for addressing antimicrobial re-
41 

sistance concerns for food animal products being evaluated for FDA approval. The 

agency has no plans to make any significant changes to this preapproval assessment 

process as this time. 

FDA recognizes the importance of maintaining the availability of effective antimicrobial drugs for treating, controlling, and preventing disease in animals. However, the agency believes it is critically important that antimicrobial drugs be used 

as judiciously as possible in an effort to minimize resistance development. The agency is currently considering strategies for addressing this issue. 

NATIONAL ANTIMICROBIAL RESISTANCE MONITORING SYSTEM

Question. The National Antimicrobial Resistance Monitoring System—NARMS— 

is a critical tool for the entire food chain. How do you ensure the money is used 

appropriately and goes towards NARMS surveillance and not other activities? 

Please provide, for the record, a distribution of NARMS funding by activity. 

Answer. As you indicate in your question, the National Antimicrobial Resistance 

Monitoring System—NARMS—is a critical tool for the entire food chain. We take 

this responsibility and the use of funds designated to this public health tool, very 

seriously. FDA has established financial safeguards—for example, auditing and reporting—in our funding allocation and expenditure financial system to ensure that 

funds intended for NARMS and other critical programs are expended on those activities only. 

The following is a distribution of NARMS funding by activity for fiscal year 2008, 

the last year that actual amounts for a fiscal year are available. 

[In millions of dollars] 

USDA ............................................................................................................................................................... 1 .4 

CDC ................................................................................................................................................................ 1 .8 

FDA ................................................................................................................................................................. 3 .5 

Total .................................................................................................................................................. 6 .75 

PERSONALIZED MEDICINE

Question. In your testimony, you State that FDA ‘‘will address patient-product 

interactions that generally do not relate to manufacturing flaws.’’ In the past we’ve 

called this effort ‘‘personalized medicine’’—trying to make sure certain populations 

that are genetically predisposed to a bad reaction to a treatment are screened in 

advance and not given the treatment. 

This initiative has an alternate goal too. In some cases, certain populations are 

genetically predisposed to have an overwhelmingly positive reaction to a treatment. 

We also want to be able to find these patients and make sure they get the treatment 

that is best for them. 

What is your vision for this proposal? Will FDA engage industry during the drug 

development or clinical trials process to help isolate these unique populations? Or, 

will FDA work with industry to conduct studies after approval? 

Answer. Our vision and evolving practice with regard to personalized medicine is 

to study genetic, molecular, and patient-specific factors that can affect an individual’s response to drugs or medical devices. Our efforts will continue to span the continuum of a medical product’s lifecycle, which includes discovery, development, and 

use by the public with a focus on both safety and efficacy. 

In the pre-approval setting, we will continue to work with industry to use 

pharmacogenetic principles to identify optimal doses for patients, specific patient 

characteristics that would confer a better chance of taking a medical product that 

works and populations with unmet medical needs. These efforts help the industry 

bring products to market and help large segments of the public. 

For drugs to be targeted to the right patients, it is usually necessary to have a 

diagnostic test that can accurately identify just who the right patients are. We have 

discovered through ongoing interactions in this area with industry that upfront 

guidance and advice is needed, and close cooperation between FDA and industry, 

as well as between FDA’s product centers is essential. For these reasons, we have 

established groups within the Center for Drug Evaluation and Research and the 

Center for Devices and Radiological Health that have specific expertise to focus on 

personalized medicine issues and work to make sure that the personalized medicine 

vision moves as quickly and as smoothly as possible within the confines of our regulations. We expect that as new drugs are developed and are beginning clinical trials, 

we will be able to provide timely advice to the drug and device manufacturers to 
42 

assure that the test and the drug are ready for patient use at the same time, and 

that the combination is really working as we expect it to. 

We also have begun working with sponsors of drugs that are already on the market to implement tests that can make the drug work better, by determining 

postmarket whether there are certain identifiable populations that can gain benefit 

more than others, or populations that would be harmed by exposure to the drug. 

After a drug is approved, we continue to protect the public health by including important pharmacogenetic information in drug package inserts. Some notable examples include drugs used by millions of people worldwide such as the blood thinner 

warfarin, marketed as Coumadin, the anti-platelet drug clopidogrel, marketed as 

Plavix, the HIV medication abacavir, marketed as Ziagen, and the seizure medication carbamazepine, marketed as Tegretol. These efforts give clinicians a better understanding of why patients respond to medications so differently, and in some cases 

prevent life-threatening events such as serious bleeding, ineffective treatment, and 

fatal allergic reactions. 

In addition to drug development initiatives and labeling updates, we will continue 

to build our research infrastructure. We have established relationships with universities, pharmacy benefits managers, healthcare systems, personalized medicine coalitions, and sister HHS agencies, AHRQ and NIH, to answer questions related to 

drug response variability, and to create dialogue among many constituents to advance the public health mission of FDA. In summary, our vision is one where information on a drug’s benefits and risks can be applied to individual patients using 

new knowledge and interventions developed through our involvement both before 

and after a drug are approved. 

HUMAN RESOURCES/HIRING ISSUES

Question. In 2004, The Department of Health and Human Services—HHS—consolidated all human resource functions into 5 servicing centers. FDA, along with 

several other agencies, is serviced by the Rockville Human Resources Center. 

It has recently come to my attention that an internal audit conducted by HHS 

found that the Rockville HR Center, which services FDA, was failing in many areas. 

As a result, this center lost its authority to hire individuals from outside the government. HHS has implemented a process to work around this situation. However, this 

process has added time to FDA’s service agreement, and FDA has had to independently contract with the Office of Personnel Management—OPM—for some personnel 

actions. It may be more than a year before the Rockville HR Center gets all of its 

authority back. 

Given that the subcommittee has invested significantly in FDA by increasing the 

agency’s budget by more than 39 percent since 2006 and that FDA is in a hiring 

surge right now, I take this situation very seriously. Currently, FDA is paying HHS 

for a service that is not being provided as contractually agreed, and is also outsourcing additional human resource activities to OPM in order to fill the gap left by the 

Rockville HR Center. 

Can you update us on this situation? How does this affect FDA’s ability to bring 

qualified employees onboard? 

Answer. The significant budget increases resulting in a surge of hiring at FDA 

coupled with the Rockville HR Center’s loss of outside hiring authority have 

strained the capacity of the FDA to effectively bring on the best qualified individuals. FDA can lose highly qualified candidates because of a new quality review process that has increased the time it takes before vacancies are advertised, certificates 

are issued and job offers are made. 

FDA is working closely with HHS to address this situation. 

Question. Since FDA is independently contracting with OPM for certain services, 

essentially paying two organizations for one job, would allowing FDA to send all 

personnel actions through OPM or allowing FDA to conduct human resource actions 

‘‘in house’’ be a more preferable arrangement for the agency? 

Answer. Allowing the FDA to send all personnel actions through OPM is not an 

idea that has been fully researched. FDA would need to consult with OPM on its 

ability to provide such extensive staffing services for the Agency as we are not 

aware that OPM has the capacity to serve a large agency. 

Ideally, in order for FDA to be successful and effectively manage its human capital, FDA is in need of a HR solution that provides more a strategic concentration 

and alignment with its human capital goals with business needs, that is customer 

focused, that ensures effective policy and practices are in place, that is appropriately 

structured, resourced and supported and that has staff with an extensive understanding of the client and its mission. FDA is working closely with HHS to develop 

such a solution. 
43 

FOREIGN OFFICES

Question. In fiscal year 2008, the subcommittee provided funding for FDA to begin 

the process of opening offices in foreign countries. For the first time, FDA employees 

are permanently stationed in countries like China and India that export a lot of 

FDA-regulated products. Can you update us on the status of the foreign offices? 

Where are they located and are they fully staffed? 

Answer. I am happy to provide the status of FDA foreign offices. The location of 

FDA’s foreign offices and their status are listed below. The persons who have been 

hired but have not yet reported to their duty posts are training for their assignments as well as undergoing the various Department of State clearances required 

of them and their families. They are also performing various assignments pertaining 

to their future deployment from their current duty stations in the United States and 

through temporary duty assignments in-country. 

China.—A total of 8 FDA staff will be posted in three locations, Beijing—4, 

Shanghai—2 and Guangzhou—2. The locations were opened in November 2008. At 

this time, only the Country Director is posted in-country. By June 1, 2009, four additional FDA staff will be posted in-country and the remaining three by the end of 

July. 

India.—A total of 12 FDA staff will be posted in two locations, New Delhi and 

Mumbai. The New Delhi office opened in January 2009. At this time, only the Acting Country Director is posted in-country. By July 1, 2009, five additional FDA staff 

will be posted in-country, one by July 30, 2009, and another by November 1, 2009. 

Four additional hires will be made and deployed in-country early in CY 2010. 

Latin America.—A total of 7 staff will be posted in three locations, Costa Rica, 

Chile and Mexico. The San Jose, Costa Rica office opened in January 2009. At this 

time, only the Regional Director is posted in-country, in Costa Rica. By August 15, 

2009, 4 additional FDA staff will be posted in-country. Two additional hires will be 

made and deployed in country early in CY 2010. 

Europe.—A total of 3 staff will be posted in three locations: Brussels, Belgium; 

London, England—the European Medicines Agency; and Parma, Italy—the European Food Safety Agency. The Brussels location opened in December 2008. At this 

time, only the Regional Director in Brussels is posted in-country. The staffer for the 

London location will be posted in-country on June 22, 2009. The staffer for Parma 

will be hired and posted in-country in early CY 2010. 

Question. Do you have any specific examples of how staff located in foreign countries has made FDA-regulated products exported to the United States safer? 

Answer. The primary purpose of posting FDA scientists and inspectors overseas 

is to engage more proactively and consistently with various communities—regulatory, industry, and third parties—in strategic regions abroad to help FDA better 

accomplish its domestic mission to promote and protect the public health of the 

USA. FDA staff in foreign countries do this by helping FDA acquire more robust 

information based on which the Centers and ORA can make the necessary decisions 

to help assure the safety, efficacy—as appropriate—quality, and availability of FDAregulated products. To this end, FDA officials abroad are involved in the activities 

described below. 

FDA is working with counterpart agencies in countries where we have foreign offices, gathering better knowledge about the production of FDA-regulated products 

and their transport to U.S. ports. FDA is also working with trusted counterpart 

agencies to leverage scientific, inspectional, and other resources. When requested, 

FDA is engaging with developing counterpart agencies to help build their regulatory 

capacity. In addition, FDA is working with private and public sector trusted third 

parties, and we are providing helpful information about industry compliance with 

FDA regulatory standards. FDA is also working with regulated industry to provide 

greater information about the applicable standards for their products to be admitted 

to the USA. FDA is engaging with U.S. agencies that are already present in foreign 

countries]that have complementary missions to FDA. 

An example of how FDA staff located in foreign countries has helped make FDAregulated products safer is the situation with contamination of various dairy and 

dairy-containing products from China that were found to contain melamine or its 

analogs. FDA issued an Import Alert just prior to the FDA office’s opening in Beijing. The FDA Country Director facilitated collaboration with the Chinese Government to address the problem in an expedited manner. 

FISCAL YEAR 2009 SUPPLEMENTAL FUNDING

Question. In fiscal year 2009, FDA received $150 million in supplemental funding 

to jump start activities that would be funded with the regular fiscal year 2009 appropriations bill. Nine months after this funding was provided, FDA has spent about 
44 

$30 million. The agency only has only 4 months, until September 30, 2009, to spend 

the remaining $120 million. Does FDA have a plan to spend the remainder of this 

money or will it go back to the Treasury at the end of the fiscal year? Answer. FDA has a plan in place to spend the $150 million provided in the fiscal year 2008 Supplemental. FDA has designated $30 million of the Supplemental for 

Information Technology—IT—and FDA is at various stages of the procurement process to spend the unobligated balance of the $30 million so that the contract awards 

will be made by the end of this fiscal year. Further, FDA planned to add 324 staff 

with funds provided by the fiscal year 2008 Supplemental, and FDA has achieved 

approximately 83 percent of that staffing goal. The balance of the year will see a 

steep acceleration of spending of the fiscal year 2008 Supplemental funds for payroll 

and related operational costs, and the obligation of contracts for IT projects and purchase of equipment. 

CRITICAL PATH INITIATIVE/MODERNIZE DRUG DEVELOPMENT

Question. In March of 2004, former Commissioner McClellan referenced a need to 

modernize development paths and processes back in FDA’s ‘‘Innovation or Stagnation’’ document which led to the Critical Path initiative. It’s been more than 5 years 

now. Over the past 2 years the subcommittee has provided more than $23 million 

for the critical path initiative. Do you think that initiative has been a success and 

why/why not? 

Answer. The Critical Path Initiative—CPI—is an unequivocal success. CPI is leading the Sentinel Initiative, working to develop and implement America’s first active 

system to enable FDA to query large health information databases and monitor, in 

real time, medical product safety and efficacy. CPI is modernizing the electronic portal MedWatchPlus, enabling better and more complete adverse events reports. 

In an FDA collaboration with the Serious Adverse Events Consortium, a genetic 

link has been identified associated with acute liver injury in some people who take 

the antibiotic Flucloxacillin. SAEC is making publicly available to researchers 

pooled data on genetics associated with drug-induced skin rashes like Stevens-Johnson syndrome. In 2007, FDA approved a new genetic test to help physicians assess 

whether a patient is especially sensitive to the blood-thinner warfarin and updated 

the label. In 2006 and 2007, FDA’s CPI launched more than 40 research projects. 

In 2008, CPI researchers collaborated with 84 government agencies, universities, industry leaders and patient groups from 28 States and 5 countries on 60 research 

projects that are speeding the development of innovative therapies and safety monitoring systems to treat killers like tuberculosis, cancer, and Alzheimer’s. 

CPI is modernizing the clinical trials enterprise to increase the quality and efficiency of clinical trials and ensure trial participant safety. As part of a personalized 

medicine initiative, CPI research has identified genetic biomarkers that are being 

explored for their value in making medicines safer and more effective. CPI is supporting and leading innovations needed to transform FDA into a robust, 21st-century regulatory agency. CPI is implementing cutting-edge information systems vital 

to supporting medical innovation and public health safety, like e-management of 

clinical study information and an e-platform to move FDA’s largely paper-based infrastructure to a fully automated system. 

OFFICE OF GENERIC DRUGS

Question. Dr. Sharfstein, last year the Committee expressed interest in adequate 

funding for the Office of Generic Drugs—OGD—an interest which still remains. As 

FDA has noted, almost 70 percent of prescriptions are now filled with generics; it 

is obvious that in an environment emphasizing greater need for cost control, one key 

area that has been successful in achieving savings has been greater reliance on 

quality generic drugs. 

Last year, FDA advised the Committee that OGD’s target was 1,900 actions for 

fiscal year 2009, including approvals, tentative approvals, not approvable and approval actions on applications. FDA stated that the agency was on track to achieve 

that goal and to exceed the fiscal year 2008 number of 1,780 actions. Could you update us on the actual progress made in each of these categories? Please outline the 

reasons why you believe FDA has either been exceeding or failing to meet those 

goals. 

Answer. The Office of Generic Drugs—OGD—had 1,779 total actions in fiscal year 

2007 and in fiscal year 2008, a total of 1,933 actions. The Office is expecting to meet 

the fiscal year 2009 goal of 2,033 actions. As of the end of May 2009, OGD had 

taken 399 approval or tentative approval actions and 941 not approval actions for 

a total 1,340 actions. The average for the 8 months is 167. To meet the goal, the 

average for the remaining months must be 173 actions per month. OGD believes it 
45 

will achieve that average because there has been an upward trend of actions per 

month related to newer reviewers becoming more productive. 

Question. Last year, FDA stated that the fiscal year 2003–2005 cohort approval 

time was 16.6 months and that the yearly median time to approval increased due 

to the escalating workload. Please update those numbers for us. We are interested 

in seeing recent numbers relating to how long oldest ANDAs which are still under 

review have been pending before the FDA. In July, 2008, the agency advised the 

Committee that there was one ANDA pending for 11 years, 9 pending over 9 years, 

and about 100 pending for more than 4 years. Could you provide us with an updated 

status report on those numbers? What emphasis is being placed on clearing this 

backlog? What are the reasons for these delays? 

Answer. The median time to approval currently stands at 21.6 months. This includes both the time with the Office of Generic Drugs—OGD—and the time with 

the applicants as they prepare responses to deficiencies that FDA identifies. 

Approval time has been increasing due to the number of pending applications. 

There are currently 137 applications that have been pending longer than 4 years. 

There are a variety of reasons for certain applications remaining as pending for a 

long time. Some are pending because of the need to achieve a satisfactory inspection 

result. Others are pending because the sponsor firms are subject to the application 

integrity policy that precludes FDA approval. Others may be held up because of patents, 180-day exclusivity, or other legal matters. Others have complicated scientific 

matters that require additional review time and subsequent additional review cycles. While OGD tries to be as efficient as possible in the review process, OGD officials want to be certain that all deficiencies and scientific issues are addressed before approval. 

The number of pending applications remains at around 1,600 applications. OGD 

is concerned about the number of pending applications and the office would like to 

clear the backlog. However, the OGD continues to receive more applications than 

it can act on each month. Within the group of pending applications, there are applications that cannot be approved because of patents or exclusivity on the reference 

drug, and there are applications that have had at least one review cycle. In addition 

to the workload of original abbreviated new drug applications—ANDAs—OGD receives around 350 supplements per month for post-approval manufacturing changes 

that also require review and action. 

Question. FDA also advised the Committee in 2008 that many of the old, pending 

ANDAs ‘‘have challenging scientific issues with respect to determination of bioequivalence resulting in extended review periods.’’ This acknowledgement of potential scientific inadequacies at OGD is of concern. In February, OGD Director Gary 

Buehler stated his goal of fully staffing two bioequivalence divisions and adding a 

third division. He also indicated his priority in securing additional microbiologists 

and recruiting a pharmacologist/toxicologist to enhance the Office. What actions 

does OGD take to address these challenging scientific issues? What progress has 

been made toward reaching Mr. Buehler’s goals? To what extent is OGD using, or 

could it be placing more emphasis on using, the scientific capabilities of other offices 

within CDER for the more complicated scientific reviews? We are interested in 

learning whether, then, the backlogs at OGD are strictly a matter of resources, a 

question of where the resources are being placed, or a lack of collaboration within 

FDA agency-wide? 

Answer. The Office of Generic Drugs—OGD—continues to work under a structure 

of two Divisions of Bioequivalence and three functioning Divisions of Chemistry. The 

addition of another division in both the chemistry and bioequivalence review areas 

would enhance review efficiency. During 2008, OGD hired 10 microbiologists, and 

the office now has 17 on staff. That business unit is steadily increasing review output as new microbiology reviewers become more productive. OGD has developed the 

position description for a pharmacologist/toxicologist, and the office will advertise 

that position soon. 

In addition, OGD has increased its science staff over the past year. OGD scientists assist the review divisions by addressing challenging scientific and review 

issues. The Science Staff in OGD oversees contracts for studies with outside groups. 

OGD uses the scientific capabilities of other offices and collaborates with scientists Agency-wide by routinely consulting experts in other components of the Center for Drug Evaluation and Research, seeking opinions on clinical matters from 

physicians in specialty areas, seeking concurrence on bioequivalence assessments 

from the Office of Clinical Pharmacology, using statisticians from the Office of 

Translational Sciences, assessing potential safety matters through consults to the 

Office of Surveillance and Epidemiology, requesting input on questions of 

immunogenicity from the Office of Biotechnology Products, requesting certain lab-
46 

oratory research from the Office of Testing and Research, and using the services of 

the Advisory Committee for Pharmaceutical Science. 

Managing and reducing the backlog of applications requires ensuring OGD has 

the right number of staff are on board, has the right skill sets to address the various 

scientific issues, and continues coordination and collaboration with the right staff 

within FDA. OGD continues to manage and reduce the backlog using this threepronged strategy. 

Question. The President’s budget relies on substantial resources for OGD and its 

field activities through a new Generic Drug User Fee. As you know, this fee has 

been proposed in the past and was not implemented. How optimistic are you that 

such a user fee can be enacted this year, and what activities have you undertaken 

to develop a specific proposal and when might the Committee learn more about this? 

Answer. Although generic drug user fees have been proposed in previous budgets, 

FDA plans to reengage the generic drug industry in user fee discussions this year 

to make progress on this important proposal. Our aim will be to develop a user fee 

program that provides the FDA generic drug program with the resources needed to 

modernize and enhance the capacity of the generic drug review process and to ensure timely patient access to safe and effective new generic drugs. FDA believes that 

the resources in the fiscal year 2010 proposed generic drug user fee program are 

necessary to reduce the review backlog and ensure patient access. Although there 

are uncertainties associated with any new user fee discussions, FDA believes that 

successfully concluding discussions with stakeholders will promote the important 

goals of timely patient access to safe and effective generic drugs. 

Question. The Food and Drug Administration Amendments Act of 2007—Public 

Law 110–85—contained a new provision intended to speed the agency’s review of 

Citizen Petitions. Could you provide the Committee with estimates of how many petitions you have reviewed under this new authority and the timeframe for that review? How many petitions were pending before enactment of Public Law 110–85 

and what is their status? 

Answer. Section 914 of the Food and Drug Administration Amendments Act of 

2007—FDAAA—added section 505(q) to the Federal Food, Drug, and Cosmetic Act— 

the Act. This amendment requires that FDA respond to certain petitions regarding 

the approvability of certain applications within 180 days. Specifically, new section 

505(q) applied the 180 day timeframe to citizen petitions and petitions for stay of 

agency action that pertain to the approvability of a pending application submitted 

under section 505(b)(2) or (j) of the act—generic drug applications. This complex provision of FDAAA took effect upon enactment—September 27, 2007. Therefore, FDA 

has had to interpret the new provision and develop implementing procedures while 

simultaneously addressing citizen petitions and petitions for stay that are subject 

to the new requirements. 

FDA has received 40 citizen petitions as of May 20, 2009 that is subject to section 

505(q) and has responded to 29 of those petitions as of May 20, 2009. Of the 29 

responses, 28 were answered in 180 days or less. The remaining 505(q) petitions 

have been pending with the agency fewer than 180 days. 

Prior to enactment of FDAAA, there were approximately 216 citizen petitions 

pending, of which approximately 73 raised issues about the approval standards for 

generic applications, patents or exclusivity, or other issue that could delay approval 

of generic applications. Not all of the 73 pending petitions would have been subject 

to section 505(q) even if they had been submitted after it passed. We have completed 

approximately 21 of these 73 petitions, and 29 of the other backlogged petitions, 

since the passage of FDAAA. 

SUBCOMMITTEE RECESS

Senator KOHL. At this time, we will bring this hearing to a close, 

and the subcommittee will stand in recess until June 4 when we’ll 

be talking about the USDA budget request. 

Thank you very much. 

Dr. SHARFSTEIN. Thank you. 

[Whereupon, at 3:02 p.m., Tuesday, May 19, the subcommittee 

was recessed, to reconvene subject to the call of the Chair.] 
(47) 

AGRICULTURE, RURAL DEVELOPMENT, FOOD 

AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR 

FISCAL YEAR 2010 

THURSDAY, JUNE 4, 2009 

U.S. SENATE, SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, Washington, DC. 

The subcommittee met at 1:05 p.m., in room SD–192, Dirksen 

Senate Office Building, Hon. Herb Kohl (chairman) presiding. 

Present: Senators Kohl, Harkin, Johnson, Nelson, Reed, Pryor, 

Specter, Brownback, Bennett, Cochran, Bond, and Collins. 

DEPARTMENT OF AGRICULTURE 

OFFICE OF THE SECRETARY

STATEMENT OF THOMAS VILSACK, SECRETARY 

ACCOMPANIED BY: 

DR. KATHLEEN MERRIGAN, DEPUTY SECRETARY 

DR. JOSEPH GLAUBER, CHIEF ECONOMIST, U.S. DEPARTMENT OF 

AGRICULTURE 

DR. SCOTT STEELE, BUDGET OFFICER, U.S. DEPARTMENT OF AGRICULTURE 

OPENING STATEMENT OF SENATOR HERB KOHL

Senator KOHL. Good afternoon to everybody. We would like to 

welcome Secretary Vilsack back to this subcommittee at this time 

to present the administration’s fiscal year 2010 budget request for 

USDA. The Secretary is accompanied by Dr. Kathleen Merrigan, 

Deputy Secretary; Dr. Scott Steele, the USDA Budget Officer; and 

Dr. Joseph Glauber, the USDA’s Economist. We thank you all for 

being here with us today. 

The fiscal year 2010 budget for discretionary programs at USDA is $21.25 billion. This is an increase of $1.9 billion from last year, 

or nearly 10 percent. At first glance, this appears to be a very robust budget and in many important ways, it indeed is. 

The WIC program, which many of us consider essential, has been 

underfunded in recent executive budgets. By contrast, this budget 

includes an increase of $917 million so that we can deal with increased food costs and maintain participation. 

The rental assistance program would see an increase of $189 million to prevent a large number of poor rural residents, many of 

them elderly, from losing their homes. 
48 

And funding for humanitarian food aid has increased by $564 

million. 

These three changes alone make up nearly 90 percent of USDA’s 

total budget increase. Just to repeat that, these three items alone 

make up nearly 90 percent of the total increase in the budget. 

The rest of the money goes quickly. Information technology at the Department would see an increase of $117 million. These funds 

are necessary to improve USDA data security and make sure computer systems do not fail. Without them, we run a significant risk 

of delayed farm payments and deferred farm bill implementation. 

USDA energy programs, which we hope will help lead our Nation toward a renewable energy future, receive an $80 million increase. 

The Food Safety and Inspection Service budget includes an in- crease of $47 million to provide more inspections and improve information systems. 

There are obviously more increases, but I will leave those for the 

Secretary to discuss. I would like to point out, however, that a portion of these increases are made possible only by reducing mandatory farm bill spending to the tune of $678 million. This is nearly 

$200 million more in cuts than we took last year. While I appreciate the Department’s mandate to find offsets to fund the President’s initiatives, I am certain you understand the precarious situation these farm bill cuts create in Congress. 

Mr. Secretary, our Nation has significant challenges ahead, and 

this budget lays out a plan to begin addressing them, but I have 

feared for some time that many do not fully appreciate the breadth 

of USDA’s mission or why these investments are important. 

All of us enjoy greater food safety because of USDA. Nearly one 

in five Americans participate in USDA nutrition programs. USDA 

research is developing better crops and energy systems whose benefits are widely spread across our society. 

Rural development programs bring safe drinking water, affordable housing, and essential community facilities to regions that 

would otherwise almost certainly be overlooked. These are all important tasks that demand thoughtful, deliberative treatment in 

the appropriations process. 

So, Secretary Vilsack, I—and I am sure everybody else—am very 

pleased that you’re here. We all believe that you will do an outstanding job, and we look forward to working with you in the coming years. 

After other opening statements from Senators, Mr. Secretary, the 

floor will be yours. 

Senator Brownback. 

STATEMENT OF SENATOR SAM BROWNBACK

Senator BROWNBACK. Thank you very much, Mr. Chairman. 

Welcome, Mr. Secretary. Good to have you here and good to have 

a good fellow Midwesterner in that position of Secretary of Agriculture. 

I also think it is very, very, very helpful to the Midwest that 

Iowa is the first caucus. It drives a lot of Senators to travel through 

Iowa and get to know our issues throughout the Midwest. So I 

think that is a very good thing. They formed a caucus in the U.S. 

Senate of Members of the U.S. Senate who would never, ever, ever 
49 

run for President, and there is like two people in it. So it means 

98 have got some passing interest of going through your State. And 

I am delighted you are hearing about them. 

I am glad you are at USDA. USDA touches each American’s life 

multiple times a day, food, housing programs, research and assistance. My State of Kansas is a great beneficiary of USDA programs. 

It got the first land grant university in the country at Kansas State 

University. We have got valuable USDA research. We provide valuable USDA research. My State produces a lot of food and agricultural products, and we are dependent upon that research. We want 

to see it continue. 

I want to highlight two quick areas. I really want to hear from 

you today about your targets that you want to hit as Secretary of 

Agriculture. You have a great position and a period of time in 

which you get to drive the ship, and I want to hear where you want 

to take it. 

A couple that I am very concerned about, food insecurity around 

the world. I think this is a big problem for us. It is a big opportunity for us in both providing food for people, and then I think 

getting back on agricultural development programs globally. 

I have been doing a fair amount of research and meeting with 

experts on this. In the mid-80s, we pulled out of agricultural development work in a lot of places around the world, and I think it has 

been quite harmful to us. I think there was a trend at that point 

in time, it is not really working, we do not need to do this, so let 

us pull out of it and let us just go to emergency food assistance programs. And I think we have suffered consequences because of it. 

I am going to go through that some more in questioning. 

But particularly what Senator Bond has pushed in Afghanistan 

on some of the ag development work to help us stabilize Afghanistan I think is good in a fighting region, but there is also chronic 

places like Malawi and others where agricultural developments 

continue to decline. I think we need to figure out ways we can use 

our food assistance, again, to get us back in the agricultural development game, and I think it is important to do it. 

Another one is in bioenergy. I do not think there is an area that 

the rural States are more excited about than bioenergy. Certainly 

grain-based ethanol is having some difficulty now and there is 

some consolidation taking place in that business. But it is providing a key portion of our energy equation. Our efforts in cellulosic ethanol are very intriguing and I hope will be quite successful. 

Biomass. I just came from an Energy meeting markup and we are 

looking more and more at biomass for meeting renewable energy 

standards and needs. Wind energy, although not in your purview, 

is one that generated a lot of interest and support across many 

areas of the Midwest. I cannot think of probably a better area for 

rural development than in the bioenergy field, and I want to hear 

what you want to try to do more in that particular area. 

The final point is on rural development programs. I have been 

around this for a long time. There are 90 different grant, loan, or 

standalone programs in the rural development area, and you have 

got to really question whether we need all 90 of those or if you 

would be better off with three big, well-funded ones or five maybe. 

But it just has made it so complicated that people cannot access 
50 

it or they get a little piece here and they find another piece there. 

You have got to hire somebody to find the program. I would think 

it would really be one you could break into. 

So I am delighted to have you at that position. Welcome here. 

I want to welcome Susan Collins, new to the subcommittee, as 

well. Mr. Chairman, she is going to do a great job and educate us 

about Maine agriculture and potatoes and all sorts of other things 

I am sure. Lobster, a great Maine dish. So thank you very much 

for the hearing. Welcome, Susan. 

Senator COLLINS. Thank you. 

Senator KOHL. Thank you very much, Senator Brownback. 

Other statements from Senators? Senator Pryor, Senator Cochran, Senator Bond, Senator Johnson, and Senator Collins. 

Senator Cochran. 

Senator COCHRAN. Mr. Chairman, I ask unanimous consent that 

my statement be printed in the record. 

[The statement follows:] 

PREPARED STATEMENT OF SENATOR THAD COCHRAN

Mr. Chairman, thank you for holding this hearing to review the Administration’s 

fiscal year 2010 budget request. I welcome Secretary Vilsack and other officials from 

the U.S. Department of Agriculture on the witness panel. 

Mr. Secretary, I commend you for working aggressively to implement the 2008 

farm bill. The enactment of this new law followed many hours of debate, and it 

should be implemented so as to reflect the intent of Congress. I also want to highlight the fact that production agriculture views the farm bill as a multi-year commitment from the government. In other words, I ask you to resist the urge to reopen farm bill provisions that impact the farm safety net. 

In addition, I want to mention the importance of the Natural Resources Conservation Service and its role in administering conservation programs. Programs such as 

the Environmental Quality Incentive Program, Wetlands Reserve Program and 

Wildlife Habitat Incentive Program are important to farmers and land owners 

across the United States. These conservation programs are limited by either funding 

caps or acreage caps, so it is important to wisely administer these funds to as many 

producers and landowners as possible. 

An important aspect of the Agriculture Appropriations bill is the annual funding 

provided for agricultural research. This research helps enable U.S. producers to remain the leaders in food and fiber production. We need to work toward providing 

adequate funding to continue important research initiatives. 

Mr. Secretary, I am concerned about your recent comments suggesting that agriculture may benefit from cap-and-trade offsets. It is more likely that crop producers 

will face increased input costs if Congress enacts cap-and-trade legislation. As you 

review the impact of climate change legislation on agriculture, I ask you to remember that those producing the food we eat are important to our way of life. We should 

fully consider the consequences of further increasing input costs. 

Thank you again for appearing before the subcommittee. I look forward to your 

testimony. 

Senator KOHL. Thank you so much. 

STATEMENT OF SENATOR TIM JOHNSON

Senator JOHNSON. Mr. Chairman, I ask unanimous consent that 

my full statement be entered into the record. 

I have a couple other things to comment about. I am pleased that 

with the targeting of farm program payments with the $250,000 

payment limitations cap. I am pleased that Secretary Vilsack has 

worked so hard at implementing country-of-origin labeling. 

I am also concerned for some parts of the budget, including a 

$500,000 annual sales limit for direct payments which does not reflect actual farm income. 
51 

PREPARED STATEMENT

And I look forward to working with you on issues important to 

our ag communities and to fund priorities important to South Dakota. Thank you. 

[The statement follows:] 

PREPARED STATEMENT OF SENATOR TIM JOHNSON

Chairman Kohl and Ranking Member Brownback, thank you for holding today’s 

hearing to discuss the President’s fiscal year 2010 proposed agriculture budget. 

Thank you, Secretary Vilsack, for coming to the Hill today. I’d also like to especially 

thank you for the work you’ve done to implement mandatory Country of Origin Labeling properly, which has been a priority of mine for nearly 17 years, since I introduced my first meat labeling bill in 1992. 

Agriculture has a $21.3 billion per year impact in South Dakota, and the Federal 

government’s agriculture spending priorities impact the success of our rural communities and our national food security. I am pleased to see an emphasis on many important ag priorities in the President’s proposed budget, including a targeting of 

farm program payments with a $250,000 commodities payment limit cap, Commodity Supplemental Food Program funding, and money for the implementation of 

COOL. 

I am also, however, concerned for some parts of the budget, including the 

$500,000 annual sales revenue limit for direct payments, which does not reflect actual farm income, and a plan to cut funding for the Resource, Conservation and Development Councils, which generate over five local dollars for every dollar of Federal 

investment. 

I look forward to working with you on issues important to our agricultural communities and to fund priorities important to South Dakota. Thank you. 

Senator KOHL. Thank you, Senator Johnson. 

Senator Bond. 

STATEMENT OF SENATOR CHRISTOPHER S. BOND

Senator BOND. Thank you, Mr. Chairman. I will pass up the opportunity to be as brief as some of my colleagues. 

I do want to mention one area that I think is of overall concern. 

The Food, Conservation and Energy Act of 2008 established the 

new National Institute of Food and Agriculture, or NIFA, to provide enhanced support for research, extension, higher education 

programs, dealing with all of the challenges not only that we face 

but the world faces. Research under this would encourage better 

land use management, provide efficient nutrition and nutrient and 

pesticide application, increase domestic energy production, increase 

nutrition awareness, many, many things. 

I am disheartened that the administration in this initial budget 

proposal places little emphasis on ag research and, instead of increasing our capabilities, would cut $237 million from the research, 

education, and economics portion of the USDA budget. I think that 

is a cause for concern. I will ask a question on it, but I hope, Mr. 

Chairman and Senator Brownback, that we will be able to have a 

discussion on that. 

Senator KOHL. Good. 

Senator Collins. 

STATEMENT OF SENATOR SUSAN COLLINS

Senator COLLINS. Thank you very much, Mr. Chairman. Let me 

just say that I am delighted to be a new member of this subcommittee. 
52 

I just want to express some concern also about the President’s 

budget in the area of the zeroing out of the rural empowerment 

zones and Enterprise Communities Grants Program. There is no 

funding for resource conservation and development programs. As 

my colleague has mentioned, the agricultural research has taken a 

hit. Particularly, the USDA ARS Buildings and Facilities account 

is zeroed out as well as the Healthy Forest program. There are a 

lot of concerns that I have about the priorities set in this budget. 

I am very pleased to be a new member of this subcommittee and 

to work with you, Mr. Chairman, and the ranking member, Senator 

Brownback. Thank you. 

Senator KOHL. Thank you, Senator Collins. It is great to have 

you with us. 

Senator COLLINS. Thank you. 

Senator KOHL. Mr. Secretary, we would love to hear from you. 

STATEMENT OF SECRETARY THOMAS VILSACK

Secretary VILSACK. Thank you, Senator, and Mr. Chairman, 

thank you very much for the opportunity. I appreciate the comments. 

I am going to depart from what traditionally would take place, 

which is to read a statement that is a part of what we would submit for the record, and just simply talk very briefly about the priorities of USDA. 

Let me, first and foremost, say that the budget that we are going 

to discuss today was fashioned in a fairly rapid time period, at a 

time when USDA was obviously not fully staffed and manned because we were in the process of transitioning to the new administration. So it is important, I think, for the committee to know precisely what our priorities are and how they might be reflected in 

this budget. 

Let me, first and foremost, say that we believe the USDA is an 

every-day, every-way Department. As Senator Brownback indicated, this is a Department that intersects American lives every 

single day in multiple ways. 

In order for us to reflect that role and that responsibility, we 

have a set of agenda items and priorities that really cover the wide 

range of USDA’s portfolio. 

We are very concerned about rural development and economic 

development in rural communities, and we believe that the time 

has come for a wealth creation approach to rural development that 

focuses on regional and coordinated investment, not only coordinating investments within USDA, but also coordinating those investments with other Federal investments as well as what State 

and local government is investing in economic development. We 

think there are synergies and opportunities for coordination. 

We think there are opportunities to create wealth and repopulate 

rural America. We believe that will require us to target our resources, to focus on building the infrastructure for high-paying 

jobs, starting with an expansion of broadband to unserved areas. 

This committee, this Congress, through the American Recovery and 

Reinvestment Act, saw fit to provide additional resources, and I 

will assure the committee during the course of questions that we 

are intending on putting those resources to work very quickly to 
53 

expand that very important technology to unserved areas in rural 

America. 

We want to aggressively implement the energy title provisions of 

the 2008 farm bill. We want to focus on expanding local and regional food systems for local wealth creation. We, obviously, want 

to continue a focus on value-added local commodity agriculture, 

and we want to make community facility investments that result 

in rural areas being great places to live, work, and raise families. 

We also want to make sure that we continue to promote nutrition 

and food safety. It is the goal of the President. It is the goal of 

USDA, and I suspect it is the goal of this committee to significantly 

reduce childhood obesity and hunger in this country. At the same 

time, we will work with our partners at Health and Human Services to develop a modern and coordinated food safety system. 

Our forests are extraordinarily important not only in and of 

themselves, but also for the significant role they play in preserving 

the quantity and quality of water, particularly in the Western 

United States. We want to develop an ecologically sustainable forest and private working land system with a focus on conserving 

water resources and improving water quality, while at the same 

time restoring our natural forests and linking that work with our 

conservation work on private working lands. 

We want USDA to be a modern workplace and a modern workforce. That will require working with this committee to modernize, 

stabilize, and securitize our technology so that we may be able to 

provide services more quickly and more conveniently to people in 

rural communities. 

We will focus on expanded trade promotion, particularly through 

a coordinated strategy for exporting biotechnology crops. 

We will work very hard to advance the notion of food security 

worldwide based on the principles of expanding the availability of 

food, the accessibility of food, and the utilization of food. Our focus 

initially will go on Afghanistan and Pakistan and sub-Saharan Africa. 

We also want to maintain an appropriate farm safety net. We 

will, obviously, have conversations about the proposal relative to 

direct payments, but our commitment is to work with this Congress 

to maintain a strong and adequate and appropriate farm safety 

net. We think there are opportunities for reform in crop insurance, 

and we do believe it is appropriate to focus on a $250,000 hard cap, 

but we will be glad to work with this committee on other ideas and 

other thoughts. 

Finally, we want to be a Department that makes a true commitment to civil rights, a commitment that reflects the culture and diversity of this country that is also reflected in rural communities. 

We are committed to a fair resolution of outstanding and longstanding civil rights cases against the Department, as well as a reduction and resolution of equal employment opportunity complaints 

that are currently within the Department. 

PREPARED STATEMENT

Mr. Chairman, this is an aggressive agenda. We believe that this 

budget, as presented to you, is a start. By no means will it finish 
54 

the job. We look forward to working with this committee and responding to questions that you might have. Thank you. 

[The statement follows:] 

PREPARED STATEMENT OF THOMAS VILSACK

Chairman Kohl and distinguished members of this subcommittee, it is a pleasure 

to come before this subcommittee today to discuss the details of the President’s 2010 

budget request for the Department of Agriculture. I would also like to take this opportunity to provide you an update on our efforts to eliminate wasteful and inefficient spending and to implement the American Recovery and Reinvestment Act 

(ARRA) of 2009. 

I am joined today by Deputy Secretary Kathleen Merrigan; Scott Steele, our 

Budget Officer; and Joseph Glauber, our Chief Economist. 

When I accepted this position, the President outlined three key goals for the Department of Agriculture. First, he is very concerned about the health and welfare 

of America’s children and wants to make sure our children have access to nutritious 

food. Second, he wants to make sure we do everything we can to expand the capacity of our farms, ranches, and rural communities to produce alternative forms of energy. Third, he wants to make sure we aggressively pursue the research necessary 

to allow agriculture to transition away from its significant dependence on fossil 

fuels. Fulfilling these goals will be a great challenge, particularly in the context of 

meeting challenges in the Department’s other responsibilities including food safety, 

conservation, trade, and administering the farm safety net. The current economic 

situation and difficulties of drought and other severe weather faced by large areas 

of farm country add another level of complexity to the work we have before us. 

But, with these challenges come historic opportunities for agriculture and rural 

America. I look forward to working together with this subcommittee to fulfill the 

President’s goals and our key responsibilities for the long term benefit of producers 

and all Americans. We intend to capitalize on these opportunities quickly through 

a much more effective effort to coordinate programs within the various parts of the 

Department and with other Federal, State, and local entities. 

Over the first 100 days of this administration, USDA has set out on a new course 

to promote a sustainable, safe, sufficient and nutritious food supply, to ensure that 

America leads the global fight against climate change, and to revitalize rural communities by expanding economic opportunities. We have moved quickly to respond 

to these difficult economic times by creating jobs, increasing food aid to those in 

need, and revitalizing rural communities. We have also made civil rights a top priority with definitive action to improve the Department’s record and move USDA to 

be a model employer and premier service provider. 

I look forward to working with you, Mr. Chairman, and the members of this subcommittee as we continue our hard work to ensure that USDA is at the forefront 

of change. 

IMPROVING FINANCIAL INTEGRITY

In order to improve financial integrity of the Department, I directed Subcabinet 

officials to review their agency’s financial activities for wasteful and inefficient 

spending, and report on ‘‘savings’’ each week. This has been a productive effort, 

which has resulted in the implementation of more efficient procedures and cost 

avoidance measures. The Terminations, Reductions and Savings volume of the fiscal 

year 2010 budget identifies annual savings of $19.5 million from a sample of the 

actions USDA agencies have taken. In addition, we will achieve a cost avoidance of 

$62 million in lease costs over 15 years as a result of consolidating seven leased facilities located throughout the DC metropolitan area into one location. 

As we move forward in implementing the President’s agenda, we will continue to 

root out inefficient management practices and improve our use of funds. 

RECOVERY ACT

Before I delve into the specifics of the 2010 budget, I would like to provide an 

update on our efforts to implement the American Recovery and Reinvestment Act 

(ARRA) of 2009. 

USDA received $28 billion of ARRA funding. Of this amount, almost $20 billion, 

or approximately 70 percent, is for increasing the monthly amount of Supplemental 

Nutrition Assistance Program (SNAP) benefits currently assisting over 32 million 

low-income people and increasing the block grants to Puerto Rico and American 

Samoa. 
55 

The remaining funds are for: supporting nutrition assistance programs that primarily target low-income women, infants, and children; expanding opportunities for 

broadband service in rural areas; improving community facilities, such as 

firehouses, libraries, schools, and rural medical clinics; improving drinking water 

and wastewater treatment; increasing farm assistance; promoting rural economic 

development; and supporting conservation projects to protect our Nation’s forests 

and farm land. 

Since Enactment of the Recovery Act, we Have 

—Worked with State partners to increase maximum SNAP benefits by 13.6 per- cent, which translates to an additional $80 each month for a family of four. We 

also allocated $100 million in emergency food assistance through TEFAP, and 

$25 million in administrative funds for the Nation’s emergency food assistance 

network; —Distributed all of the $173 million in Recovery Act funding for direct farm operating loans that has provided assistance to 2,636 farmers, of which approximately half were to beginning farmers and 22.8 percent were to socially disadvantaged farmers; —Announced a national signup for up to $145 million in floodplain easements and 

extended the deadline to ensure landowners impacted by flooding in States like 

North Dakota and Minnesota are given an opportunity to apply. This will restore and protect an estimated 60,000 acres of flood-prone lands; —Provided $45 million for the rehabilitation of watersheds, many of these projects 

are nearing the end of their 50-year design life. Recovery funds will be used to 

upgrade structures to current safety standards, thereby protecting life, property 

and infrastructure downstream for more than 90 years. USDA has also provided 

$85 million for 53 new flood prevention project efforts in 21 States and territories; —Made available about $760 million in funding to provide safe drinking water 

and improved wastewater treatment systems for rural towns in 38 States. 

USDA also received $2.5 billion for expanding rural broadband into communities that otherwise might not have access. USDA has begun implementation 

in concert with the U.S. Department of Commerce and is determining the best 

targeted utilization of the funding. These efforts will create jobs and revitalize 

rural communities; —Provided approximately $60 million in essential community facilities and emergency responder projects to help communities in 39 States; and —Made approximately $4.4 billion in guaranteed and direct single family housing 

loans for over 37,000 loans. 

I want to assure this subcommittee that the Subcabinet, agencies and the Department will be held accountable for not just swift implementation, but also for ensuring the funds are used efficiently and effectively. You should be confident that we 

are working hard to achieve the President’s goals to revitalize the economy. 

2010 Budget 

The President’s 2010 budget, released on May 7, 2009, proposes $21.3 billion for 

discretionary programs under the jurisdiction of this subcommittee, an increase of 

nearly $2 billion over the 2009 levels provided in the Omnibus Appropriations Act. 

This increase is primarily associated with the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), international food assistance, rural 

development and other priority programs. 

The 2010 budget reflects the President’s commitment to be transparent to the 

American people. Our budget accounts fully for the costs to operate the government. 

In addition, as I had mentioned, we have reviewed all of our operations for wasteful 

and inefficient spending. Therefore, the 2010 budget reflects a reduction of over 

$450 million for the elimination of earmarks and funding for programs that are not 

as high a priority as others, or programs that provide services that can be supported 

by other means. 

I would now like to focus on some specific program highlights. 

Nutrition 

Consistent with the President’s commitment to present an honest, transparent 

budget, we are including sufficient resources to support estimated participation in 

the nutrition assistance programs. 

For WIC, the budget proposes $7.8 billion in budget authority to support an average monthly participation of 9.8 million in 2010. This is a total increase of over $900 

million in USDA’s largest discretionary program. The budget provides $225 million 

in WIC contingency funds, for a total contingency fund of $350 million with carryover from fiscal year 2009, should costs increase beyond current estimates. Addition-
56 

ally, the budget includes $30 million to assist States in modernizing and upgrading 

their management information systems. On the mandatory side, the budget includes over $1.8 billion in increases for Child 

Nutrition Programs, to support the increased level of school lunch participation and 

food cost inflation. School lunch participation is estimated to grow to about 32.1 million children each school day, with free meal participation increasing from about 

half of the total meals in fiscal year 2008 to almost 53 percent in fiscal year 2010. 

The budget includes $5 million for Hunger-Free Community Grants authorized by 

Section 4405 of the 2008 farm bill and $0.7 million to expand the HealthierUS 

School Challenge program. In addition, the administration is proposing an increase 

of $10 billion over 10 years for reauthorization of the Child Nutrition Programs. 

These increases will support the President’s efforts to reduce childhood hunger and 

obesity by improving access to nutritious meals, to encourage children to make 

healthy food choices, and to enhance services for participants by improving program 

performance and integrity. 

For the Supplemental Nutrition Assistance Program (SNAP), the budget includes $67 billion, including $5.9 billion in Recovery Act funds, to fully fund estimated 

monthly participation and provides $3 billion in contingency funds, for a total contingency fund of $6.0 billion with carryover from fiscal year 2009, should actual 

costs exceed the estimated level. Participation in SNAP is estimated to be about 

32.6 million per month in 2009, and is projected to increase to 35.0 million in 2010. 

The Recovery Act benefit increase will remain in place until the normal cost of living adjustment catches up to the higher benefit levels. 

The budget proposes discretionary funding for the Commodity Supplemental Food 

Program (CSFP) at a level needed to maintain the current participation and continues funding for The Emergency Food Assistance Program (TEFAP). 

In order to improve the administration of nutrition programs, the budget includes 

increases in the Nutrition Programs Administration account to improve payment accuracy, advance the use of technology in benefit delivery, and enhance nutrition 

education. 

In 2010, we look forward to issuing the revised Dietary Guidelines for Americans, 

which are the cornerstone of Federal nutrition policy and the foundation on which 

all Federal nutrition education, diet and physical activity guidance, and nutrition 

assistance programs are built. The process of establishing the Dietary Guidelines requires an investment in assessing the most current and credible scientific evidence 

on which to base them, a function that USDA created and employs through its Nutrition Evidence Analysis Library. USDA will be working to update the nutrition assistance programs to reflect the latest science found in the 2010 Dietary Guidelines. 

Further, the Department will build upon its enormous success in promoting healthy 

eating habits and active lifestyles with MyPyramid, including enhancements of the 

interactive and personalized tools, such as the recent MyPyramid for Pregnant and 

Breastfeeding Women, and MyPyramid for Preschoolers. MyPyramid is an important investment in the fight on obesity and much more needs to be done in this 

area, and to increase the level of physical activity that Americans engage in on a 

daily basis. 

Food Safety 

A key responsibility I have is to make sure Americans have safe and sufficient 

and nutritious food. Although we have a strong food safety system, we need to continue to work to do a better job. We must focus on eliminating hazards before they 

have an opportunity to make anyone sick, developing technologies that will help us 

discover risks and allocate resources to reduce this risk, and during outbreaks rapidly identify and respond to incidents of foodborne illness. I am committed to modernizing the food system, focusing on preventing rather than mitigating the consequences of food-borne illness. 

For 2010, the budget requests over $1 billion for the Food Safety and Inspection 

Service. Not only will this funding will ensure that the demand for inspection is met 

as it provides for increased investments that will improve prevention, early detection, and mitigation that will reduce the adverse health impacts related to foodborne 

illness. 

The budget includes an increase of $23 million to improve the food safety Public 

Health Infrastructure. These improvements will strengthen and secure FSIS’ ability 

to target food safety inspections and investigate food safety outbreaks. In addition, 

the budget includes an increase of $4 million for additional food safety assessments. 

These assessments are conducted by a team of investigators with a broad array of 

skills necessary to conduct a comprehensive evaluation of an establishment’s food 

safety control system and potential public health risks associated with meat, poultry, and egg products. 
57 

The budget estimates that $153 million in existing user fees for voluntary inspection will be collected. For 2010, we will submit legislation to Congress that would 

authorize the collection of fees to cover the cost of additional inspection activities 

necessary for establishments with performance failures such as retesting, recalls, or 

inspection activities linked to an outbreak. 

As a member of the President’s Food Safety Working Group, I look forward to 

working with Secretary Sebelius and others to develop a strategy that will achieve 

the President’s goals to upgrade our food safety laws for the 21st century and ensure that we are not just designing laws that will keep the American people safe, 

but enforcing them. The working group will improve coordination between USDA 

and the Department of Health and Human Services and other Federal food safety 

agencies. These activities will strengthen our capacity to reduce foodborne illnesses 

and deaths resulting from foodborne illness. 

Trade 

USDA has an important role in expanding exports for our agricultural products. 

It is significant that, while the country as a whole has a trade deficit, agriculture 

has a trade surplus. USDA estimates that the trade surplus for agricultural products will be $13 billion in fiscal year 2009. To encourage further export expansion 

for our products, we need to work hard both in Washington and in our offices overseas to ensure continued access to overseas markets. I appreciate the subcommittee’s support in providing additional resources in 2009. Our 2010 budget builds on 

this foundation with $16.4 million in additional funds to meet critical needs in the 

Foreign Agricultural Service. The budget places particular emphasis on maintaining 

FAS’s overseas presence so that its representation and advocacy activities on behalf 

of U.S. agriculture can continue and on upgrading FAS’ information technology infrastructure. These funds are critical to continue our efforts to break down trade 

barriers that limit our capacity to export, such as the imposition of sanitary and 

phytosanitary barriers that are not in accord with international standards or 

science-based. As world market conditions deteriorate under the current financial 

crisis, we must be especially vigilant to ensure that we keep markets open as we 

move forward. 

Expanding our access to world markets and developing long-term trade relationships continue to be vital components of our strategy to improve the vitality of the 

farm sector and quality of life in rural areas. Due to the global credit crisis, we have 

seen a significant increase in demand for export credit guarantees provided through 

the GSM–102 program. To help meet this demand, the budget provides a program 

level of $5.5 billion for CCC export credit guarantees for 2009 and 2010. This is a 

noteworthy increase in programming from as recently as 2007, when the program 

registered sales of $1.4 billion. 

International Food Assistance 

An important focus of the Department’s international work is providing foreign 

food assistance and promoting agricultural development overseas. The administration has established the goal of renewing the U.S. leadership role in global development and diplomacy, and fostering world food security. The international food aid 

programs, such as the McGovern-Dole International Food for Education and Child 

Nutrition and Public Law 480 Title II programs, contribute to that goal by addressing food insecurity throughout the world and supporting development, health, and 

nutrition. 

In support of those objectives, the 2010 budget increases appropriated funding for the McGovern-Dole program to nearly $200 million, a doubling of the 2009 enacted 

level. We estimate the program will assist over 4.5 million women and children during 2010 at that funding level. This is a valuable program that promotes education, 

child development, and food security for some of the world’s poorest children. 

For the Public Law 480 Title II program, the budget provides a program level of nearly $1.7 billion, an increase of $464 million above the 2009 enacted level. The 

increase will reduce our reliance on the need for future emergency supplemental 

funding. Supplemental appropriations for the Title II program have been requested 

repeatedly in recent years in response to a substantial growth in emergency food 

assistance needs. In that regard, we appreciate the Committee’s favorable action on 

the supplemental request submitted by the President on April 9. 

Environmental Services Markets 

The President has made clear his priorities in addressing climate change and expanding our capacity to produce renewable energy. These priorities create significant new opportunities for farmers and ranchers to succeed. The agriculture and forestry sectors hold the potential to deliver substantial emissions reductions, including carbon sequestration, under a national climate change policy and the establish-
58 

ment of environmental services markets. The budget reflects the new course the administration has set to ensure that America leads the global fight against climate 

change, and to revitalize rural communities by expanding economic opportunities, 

while maintaining a sustainable, safe, sufficient and nutritious food supply. To create additional economic opportunities for America’s farmers and ranchers, the administration is pursuing new initiatives that reward producers for sequestering carbon and limiting greenhouse gas emissions by providing mechanisms for producers 

to generate income through environmental services markets. By seizing the opportunities presented by environmental services markets, producers will be able to transition away from a dependence on traditional farm programs. 

To this end, the budget includes an increase of $15.8 million to develop markets 

that reward producers for sequestering carbon and limiting greenhouse gas emissions. This includes $1.8 million to develop the metrics and certifications associated 

with the environmental services related to conservation and certain land management activities. We are also requesting an increase of $9 million to enhance the research and analytical capabilities of the Department related to global climate 

change and $5 million to conduct Government-wide coordination activities that will 

serve as the foundation for the establishment of markets for these ecosystem services. 

We need to ensure that farmers and ranchers capitalize on emerging markets for 

clean renewable fuels and help America reduce its dependency on foreign oil by 

helping establish the demand necessary to support increased production of biofuels. 

Renewable Energy 

The 2008 farm bill provided significant mandatory funding to support the commercialization of renewable energy. The 2010 budget builds on this investment in 

renewable energy and biobased activities by requesting discretionary funding to support almost $780 million in investments, approximately a net increase of about $275 

million from 2009. This includes increases of $218 million for loan guarantees and 

$32 million in grants to support renewable energy and energy efficiency projects 

under the Rural Energy for America Program (REAP). This request would more 

than double the amount of funding made available for REAP under the farm bill 

for 2010. In addition, the budget supports an increase of $49 million in loan guarantees for the Biorefinery Assistance Program. 

The emphasis on renewable energy research will be on production of energy crops. 

The 2010 budget proposes an increase of $11 million for the development of new 

varieties and hybrids of feedstocks with traits for optimal production and conversion 

to biofuels. The funding will also be used to develop a new data series on the supply 

and location of commodity production for renewable fuels. 

Rural Development 

USDA’s Rural Development (RD) programs provide essential support to rural 

America by providing financial assistance for broadband access, housing, water and 

waste disposal and other essential community facilities, electric and telecommunication facilities, and business and industry. 

The 2010 budget includes funding to support over $21 billion for loans, loan guarantees, and grants for the Rural Development on-going discretionary programs, an 

increase of $825 million over 2009. This makes Rural Development one of the largest lenders in the country. 

The budget will support over $7.3 billion in direct and guaranteed single family 

housing loans that will provide more than 59,000 rural homeownership opportunities. In addition, the budget includes $1.1 billion, an increase of $188 million over 

2009, to provide for rental assistance payments for 248,000 low-income households 

that reside in USDA financed multi-family housing and receive such assistance. 

This is sufficient for the renewal of all expiring rental assistance payment contracts. 

Rental assistance payments protect the rents of low-income rural residents who live 

in USDA financed multi-family housing projects. By maintaining these payments, 

we not only provide support to recipients, but also provide financial stability for 

multi-family projects that provide affordable housing to 460,000 families who live 

in these projects. 

The 2010 budget maintains significant support for infrastructure programs, such 

as the Water and Waste Disposal program and the Electric program. The budget 

funds approximately $1.6 billion in on-going direct loans and grants, an increase of 

$80 million over 2009, for essential water and waste disposal services. This program 

received an additional $3.7 billion under the Recovery Act and $300 million under 

the 2008 farm bill to reduce the backlog of applications. These investments will help 

bring increased economic benefits to rural America by providing needed water and 

waste disposal systems and by creating jobs. For the Electric program, the budget 
59 

provides $6.6 billion in funding for loans for the construction of electric distribution 

and transmission systems and to maintain existing generation facilities. This level 

of funding is sufficient to meet the expected demand for these loans. 

Increasing access to broadband service is a critical factor in improving the quality 

of life in rural America and in providing the foundation needed for creating jobs. 

The 2010 budget includes funding to support $1.3 billion for telecommunications 

loans and grants, including broadband. This funding level, coupled with the additional funding provided for USDA’s broadband programs in the Recovery Act, will 

significantly accelerate the deployment of broadband access in rural America. These 

investments will increase access to quality broadband service, which is essential to 

keeping pace in a world that relies on rapid telecommunications. 

The 2010 budget also supports $546 million in direct loans, loan guarantees and 

grants for essential community facilities, such as health care and public safety facilities; as well as $993 million in business and industry loan guarantees and $34 

million in zero-interest direct loans for intermediary relending. 

To spur the development of small business and value-added agriculture in rural 

America, the 2010 budget provides a $63 million increase for rural small business 

development in the Rural Microentrepreneur Assistance Program (RMAP), which is 

in addition to the $4 million in mandatory funding provided by the 2008 farm bill. 

An increase of $18 million is requested for Value-Added Producer Grants and nearly 

an $8 million increase for Rural Cooperative Development Grants. 

In keeping with the President’s direction to eliminate spending that is no longer 

needed, the 2010 budget does not provide any funding for the EZ/EC grants for 

which the statutory authority expires, high energy cost grants which serve a narrow 

interest that can qualify for USDA assistance under several Rural Development programs, and grants for public broadcasting digital conversion, which is due to be 

completed in June 2009. 

Diversity of Agricultural Production 

Consistent with President Obama’s desire to invest in the full diversity of agricultural production, the budget focuses greater attention on assisting the organic sector, providing greater assistance to producers of specialty crops, and supporting 

independent livestock producers. 

The budget includes an additional $2.9 million, a 74-percent increase, in funding 

for the National Organic Program, which will support enhanced outreach and education and ensure program compliance to maintain labeling credibility. 

The budget also includes additional funding for USDA to work with the fruit and 

vegetable industry to develop, establish, and operate Federal marketing agreements 

or orders that will involve quality factors affecting food safety for U.S. leafy greens 

or other fruits and vegetables. 

In an era of market consolidation, the administration will support policies to ensure that family and independent farmers have access to markets, control over their 

production decisions, and transparency in prices. This includes implementation of 

farm bill-related regulations to enhance enforcement of the Packers and Stockyards 

Act, which prohibits unfair, deceptive, and fraudulent practices. For 2010, additional 

funding is included to strengthen enforcement of the Packers and Stockyards Act. 

Proper enforcement will ensure a level playing field that fosters fair competition, 

provides payment protection, and guards against deceptive and fraudulent trade 

practices in the livestock and meat sectors. 

Research 

USDA’s science agencies have been successful in developing innovative research 

technologies and solutions to deal with the highest priority issues facing American 

agriculture. Today we are confronted with national and global challenges that will 

require both an educated workforce and pioneering scientific research to effectively 

address. The 2010 budget includes proposals to revitalize rural education and confront the challenges of global climate change, bioenergy production and childhood 

obesity. 

Consistent with the President’s pledge to make math and science education a national priority at all grade levels and revitalize rural economies, the 2010 budget 

for the National Institute of Food and Agriculture includes an increase of $70 million for research, education and extension activities. These funds will be used to provide incentives for educators in rural areas to enhance their teaching skills by establishing Rural America Teaching Fellowships, which will encourage qualified 

teachers to pursue professional development activities. The additional funding will 

allow secondary, 2-year postsecondary, and higher education institutions serving 

rural areas to update and revise their curricula and coordinate research and extension activities in the food and agricultural sciences. This initiative will also help 
60 

strengthen the teaching, research, and extension programs in the food and agricultural sciences at 1890 and 1994 Land Grant Colleges and Hispanic-Serving Institutions. Finally, a new competitive grant program, utilizing the existing infrastructure 

of 1862 and 1890 land-grant institutions, will be implemented to support rural entrepreneurship and sustain jobs in rural communities through training and the creation of web-based tools. 

The budget for the Agricultural Research Service (ARS) includes $37 million in 

increases for high priority research in areas such as childhood obesity, bioenergy, 

world hunger, and global climate change. This includes an increase of $13 million 

for a major ARS initiative to develop effective sustainable practices to help reduce 

childhood obesity through preventative measures. As past attempts at treating obesity have proven unsuccessful, research will seek to determine the barriers to individuals in following the healthful eating and physical activity recommendations set 

forth in the Dietary Guidelines as well as study family centered interventions to determine their ability in preventing obesity in children. In conjunction with this effort, ARS will work to develop new healthier foods which increase satiety, decrease 

caloric density, and increase dietary fiber. 

The 2010 budget for ARS also includes an increase of $11 million to conduct research on the development of new hybrids and varieties of bioenergy feedstocks that 

have the traits necessary for the optimal production and conversion to biofuels. ARS 

is uniquely suited to lead this research, because it maintains the National Plant 

Germplasm Collection, the world’s largest seed collection, and administers important genetic improvement and breeding programs. Research will also focus on developing strategies and technologies that will result in the sustainable, efficient and 

economic production practices of energy from forestry and agricultural products in 

ways that maintain the quality of the natural resource base. 

As I mentioned earlier, the budget supports research for global climate change 

aimed at developing mitigation and adaptation strategies through science. The 

budget proposes increases of $9 million within ARS to assess and manage the risks 

of global climate change to agricultural production and $1.8 million within the Economic Research Service budget to support research on the economics and policies 

for reducing greenhouse gas emissions. 

For the National Agricultural Statistics Service (NASS), the budget includes an 

increase of $1.8 million to establish a data series on key elements of bioenergy production and utilization which will be instrumental in developing a renewable energy 

infrastructure. The budget also includes an increase of $5.75 million to restore the 

chemical use data series which will allow the collection of data on major row crops 

on an alternating year basis. This data series will enable USDA, EPA and others 

to respond adequately to questions about agricultural chemical use and its possible 

effects on the environment. 

These program increases are offset by reductions in research and extension earmarks and lower priority projects that total about $260 million. 

Farm Safety Net 

The President’s Budget includes proposals to improve fiscal responsibility, while 

supporting a robust safety net for producers that provide protection from market 

disruptions, weather disasters, and pests and diseases that threaten the viability of 

American agriculture. I want to reassure you that the President’s Budget maintains 

the three-legged stool of farm payments, crop insurance, and disaster assistance. 

However, in keeping with the President’s pledge to target farm payments to those 

who need them the most, the budget proposes a hard cap on all program payments 

of $250,000 and to reduce crop insurance subsidies to producers and companies in 

the delivery of crop insurance. Crop insurance costs have ballooned in recent years 

from $2.4 billion in 2001 to a projected $7 billion in 2009. The President’s 2010 

budget would rein in these costs by saving over $5.1 billion over the next 10 years. 

While the budget includes a proposal to phase out direct payments to the largest 

producers, the Department is prepared to work with Congress and stakeholders as 

these proposals are considered. 

Farm Programs 

To better respond to the Nation’s economic troubles, USDA took swift action to 

implement the farm bill, and we will continue to move rapidly to implement the remaining portions of the farm bill. To that end, the 2010 budget requests an increase 

of $67.3 million to continue the Farm Service Agency’s IT modernization effort and 

activities necessary to stabilize its legacy computing environment. This funding will 

supplement the $50 million provided in the Recovery Act for FSA’s IT needs. The 

combined funds from the Recovery Act and the 2010 budget will allow us to continue to make progress in improving the delivery of farm program benefits, the secu-
61 

rity of producer information, and the integrity of taxpayer dollars by reducing the 

potential for erroneous payments. However, additional funding will be required in 

subsequent years to complete the stabilization and modernization efforts. 

Farm Credit 

USDA’s farm credit programs provide an important safety net for farmers by providing a source of credit when they are temporarily unable to obtain credit from 

commercial sources. ARRA provided substantial assistance to address the tightening 

of credit in rural areas as a ripple effect of the Nation’s overall credit crisis. Because 

the demand for credit is still high, the 2010 budget requests funding to support $4.1 

billion in direct and guaranteed farm loans, an increase of $0.7 billion over the 2009 

on-going level. 

Crop Insurance 

For the Risk Management Agency (RMA), the budget requests $80 million, an in- crease of $3 million over 2009. RMA manages the Federal crop insurance program 

in partnership with private sector insurance companies. This partnership has been 

very successful in increasing participation; however, potential instances of fraud and 

abuse within the crop insurance program continue to be identified. The President’s 

budget includes an increase of $1.8 million to provide RMA the resources necessary 

to address critical compliance needs identified by the Government Accountability Office, the Office of Inspector General, and others. This funding will help to improve 

the transparency of the crop insurance program and identify those producers, 

agents, and other program participants who would knowingly defraud the Government. 

Conservation 

The administration fully supports partnering with landowners to conserve land, 

protect wetlands, improve wildlife habitat, expand hunting and fishing opportunities, and promote other conservation initiatives. In this vein, the proposed budget 

includes several vital conservation programs, including the Conservation Reserve 

Program (CRP), Conservation Stewardship Program (CSP), the Environmental 

Quality Incentives Program (EQIP), and the Wetlands Reserve Program (WRP) that 

were authorized in the 2008 farm bill. 

These programs provide a special opportunity to address not only the Nation’s 

most serious natural resource needs but also to facilitate the administration’s goals 

of increasing energy conservation, improving renewable energy production, and reducing carbon emissions. These programs have also been instrumental in establishing and maintaining USDA’s unique partnership with land owners and operators that will be vital to our success in solving or mitigating these serious environmental and energy concerns through voluntary actions. 

The 2010 budget reflects a continued commitment to conservation by including nearly $4.7 billion in mandatory funding for those conservation programs authorized 

in the 2008 farm bill. This will support cumulative enrollment of more than 281 million acres in these programs, a 10 percent increase over 2009. CRP, which accounts 

for more than 41 percent of total funding for conservation programs, is funded at 

just under $2 billion in 2010. This level of funding will support a cumulative enrollment level of 30.4 million acres. The budget proposes spending $1.2 billion for EQIP, 

which will support enrollment of an additional 16.8 million acres through cost-share 

contracts. 

Further, the Conservation Stewardship Program (CSP) and the Wetlands Reserve 

Program (WRP) are funded in the 2010 budget. This includes $447 million for CSP 

that will be used to enroll 12.8 million additional acres, and $391 million for WRP 

to enroll a projected 152,600 acres. While the projected WRP enrollment in 2010 is 

slightly below the 2009 level, it is considerably higher than enrollment levels in recent years including more than double the level enrolled in 2008. 

The 2010 budget also includes $907 million in discretionary funding for on-going 

conservation work that provides high quality technical assistance to farmers and 

ranchers and addresses the most serious natural resource concerns. This includes 

discretionary savings of $75 million from the elimination of duplicative programs 

and programs that are not as high a priority of other programs, including the Resource Conservation and Development Program and the Watershed and Flood Prevention Operations Program. 

Civil Rights 

Ensuring equitable treatment of all of our employees and clients is a top priority 

for me. The 2010 budget includes increased resources to improve our efforts to ensure that all USDA employees and constituents are treated fairly. For too long, the 

Department has been known for prejudice and discrimination in its employment 
62 

practices and program delivery. Such practices will not be tolerated while I am Secretary of Agriculture. By holding each USDA employee accountable for their actions 

and through the implementation of my recently announced civil rights plan, we will 

strive to make the Department a model agency for respecting civil rights. In support 

of these efforts, the 2010 budget includes funding to address program and employment complaints of discrimination and to increase the participation of small, beginning, and socially disadvantaged producers in USDA programs. 

Outreach to Underserved Constituents 

Another key initiative is expansion of outreach to underserved constituents. The 

2010 budget includes funding to support establishment of the Office of Advocacy and 

Outreach authorized in the 2008 farm bill. This office will increase the accessibility 

of programs to socially disadvantaged producers, small-scale producers, and beginning farmers and ranchers and will provide them an avenue for input into the programmatic and policy decisions to improve their viability and profitability. 

The budget also provides the funding necessary to support enhanced governmentto-government relations and improve Tribal consultation and outreach activities related to USDA programs. This will enhance USDA’s understanding of the diverse 

needs of Indian Tribes and the impacts of programs on Tribal organizations and 

communities. 

Department Management 

In addition, the budget also supports efforts to improve the management and 

oversight of Departmental programs. Increased funding is being sought for management priorities, including: 

—Instituting a Department-wide cyber security initiative to eliminate critical 

vulnerabilities that threaten the integrity of the USDA network and the security and privacy of Departmental systems and information. The budget includes 

an increase of $45.8 million to ensure that USDA can reliably deliver its broad 

portfolio of programs in a secure IT environment. 

—Providing oversight of program delivery by conducting audits and investigations 

and limiting fraud, waste, and abuse throughout USDA. 

—To make USDA more open and its processes more transparent, the budget includes funding for enhanced communications capabilities; tools for improved 

public access to the appeals process; and additional oversight to improve USDA 

reporting to the public on programmatic spending. 

Conclusion 

We have begun the process of making tough decisions about where our priorities 

lie and have made some tough choices about where we spend our resources. These 

choices reflect the new direction the President wants to take the country at this historic time—a track that takes the Nation on the path to recovery and provides the 

foundation and diverse opportunities for farmers and ranchers to succeed. 

That concludes my statement. I will be glad to answer questions you may have 

on our budget proposals. 

Senator KOHL. Thank you, Mr. Secretary. 

We will start our round of questioning with 5-minute events. 

AMERICAN RECOVERY AND REINVESTMENT ACT FUNDS

Mr. Secretary, the Economic Recovery Act included substantial 

resources for USDA, including $11 billion for housing loans, $3 billion for business loans and grants, $3.75 billion for water and 

wastewater loans and grants, as well as other funds. We know this 

placed a huge burden on the Department to quickly identify and 

fund the good projects. 

Do you foresee impediments to effectively utilizing all of the Recovery Act funds in a timely manner, and does this effort complicate the effective use of your annual appropriations? 

Secretary VILSACK. Mr. Chairman, we appreciate the opportunity 

that the American Recovery and Reinvestment Act has given us to 

invest in appropriate investments across the wide spectrum that 

you have identified with your question. 
63 

Let me simply report to you and to the committee that we have 

been very aggressive in our efforts to implement the Recovery and 

Reinvestment Act. To date, USDA has provided 37,057 home loans, 

single family housing loans, which has allowed us to reduce a significant backlog. To date, with the recovery and reinvestment resources, we have provided 2,636 direct operating loans to farmers 

and ranchers in need. 

At the same time, we have begun the implementation of the expanded Supplemental Nutrition Assistance Program benefits which 

has on average provided an additional $80 a month for a family of 

four. For the benefit of the committee, these resources are expended by those families, 97 percent of them, within 30 days, and 

the reality is that for every $5 we invest in that specific program, 

we get $9.20 of economic activity. It is, indeed, a direct stimulus. We have provided over $615 million for safe drinking water and 

improved wastewater treatment facilities in rural communities in 

34 States. 

We have announced $357 million in funding for Forest Service 

projects. We have fully obligated the $100 million that you all provided for 

the National School Lunch Program. 

We have also obligated $100 million for The Emergency Food Assistance Program. I was recently in Kentucky at a food bank. I cannot tell you how appreciative the food banks of this country are for 

the commitment that you have made. In that one facility alone, an 

additional 172,000 meals will be served as a result of the commitments and resources they received, and I am pleased to say that 

many of those meals will be high-protein meals with pork and poultry being two particular commodities that they were able to purchase. 

We have awarded $85 million—I think we have committed $145 

million for available watershed operations projects. We have 

awarded $45 million for watershed rehabilitation programs to rehabilitate dams and critical public health and water quality issues. And we have provided over $60 million in funding for community 

facilities in 39 States, including a number of fire, police, and medical vehicles. 

So we have rapidly implemented, as best we can, a substantial 

portion of the recovery and reinvestment proceeds. 

To your question in terms of its impact, this has, obviously, 

placed some stress on our staff, but I would suggest it has probably 

placed a greater stress on the staff of OMB, which sometimes 

makes it difficult for us working with those hard-working folks at 

OMB to get all of the rules and regulations out for the many programs that the USDA has responsibility for. I am sure we will 

touch on a few of those by the time the questions are finished 

today. 

Senator KOHL. Very good. 

Senator Brownback. 

Senator BROWNBACK. Thank you, Chairman. 

NATIONAL BIO AND AGRO-DEFENSE FACILITY

A couple questions in some broad areas. One, I want to start off 

with, though, narrowly is the NBAF facility was recently an-
64 

nounced in Manhattan, Kansas, the National Bio and Agro-Defense 

Facility. The physical plant is owned by Homeland Security. It is 

operated by USDA. 

Do you know USDA’s plans to transition it from Plum Island, as 

far as when the actual personnel will be moved to expand this expanded mission at NBAF? 

Secretary VILSACK. Senator, I am not sure that we have a specific time table for transition. We are aware of the fact that this 

is an important step for us to take in terms of our homeland security and biosecurity. 

This new facility will provide us expanded space. It will also provide us BSL–4 capabilities which we currently do not have. 

We are working with the Department of Homeland Security, and 

we have identified with the Department of Homeland Security a 

variety of research opportunities at that facility once it gets in 

place. We are concerned, obviously, as I am sure you are, about foot 

and mouth disease, classical swine fever, African swine fever, Rift 

Valley fever, and a variety of other diseases. We will be working 

very closely with Homeland Security to get this transition done as 

quickly as we can because it is an important facility. 

Senator BROWNBACK. Good. 

HUMANITARIAN FOOD AID DOLLARS

I want to show a quick chart we had done up on food aid. The 

big area that I have got concern with in food aid—I have worked 

in this region for some period of time, worked with a number of experts on it, a very important program that we have. I think it is 

a critical diplomatic program. I think it is a critical humanitarian 

program. I think it is critical for us in making our new efforts on 

HIV/AIDS in Africa and malaria work because if we are going to 

treat people and they have got a poor diet, they do not do very well. 

They need a good diet to go along with it. 

The troubling aspect of this chart is that we have increased funding substantially over the past 8 years and our tonnage has gone 

down dramatically in that same period of time. We are at a point 

now where roughly 65 percent of our food aid dollars go for two 

areas, administration and transportation. I am hopeful we start 

looking at ways that we can get people well fed and try to get that 

piece of it in a more controlled fashion, if possible. 

I do not know if you are aware of this. These are GAO studies. 

This chart is from the GAO. They are very engaged on this. I know 

the chairman cares deeply about food aid. It has got to be done 

right, but a 65 percent number just seems way high to me on those 

two areas. 

Do you have any comments? 

Secretary VILSACK. Several. First and foremost, we recognize the 

important role that food aid plays in terms of America’s role internationally, which is one of the reasons why we have suggested and 

proposed, as you know, an increase in the McGovern-Dole program. 

That has been a very successful program. 

Senator BROWNBACK. It has broad bipartisan support. People like 

that one. It is good. 

Secretary VILSACK. Broad bipartisan support and for good reason. We can assist over 4 million children in 19 countries. In fact, 
65 

it has been so successful that some countries have actually taken 

that model and adopted it for themselves and have actually moved 

away from a reliance on our program. 

As you well know, there are certain restrictions and limitations 

in terms of how resources that we do provide in food aid are transported to countries. I would say that we are focused on a—— 

Senator BROWNBACK. Can I get right at that? My time has run 

out. I am not going at that. That is an old fight around these 

places, and I do not think we ought to engage that fight. I just 

think we have got to somehow get our pencils sharper on the 

amount that we are going at the administration and transportation 

number. But to go at that fight, I have been around this one too 

long, and it will not get us anywhere. 

Secretary VILSACK. Well, I am not disagreeing with you. I am 

just pointing out that that is one of the explanations for the chart 

that you have placed up there. 

Let me suggest a different way, Senator, if I might. 

Senator BROWNBACK. Please. 

Secretary VILSACK. Let me suggest that one way that we could 

perhaps move this process forward is to focus on how we might be 

able to use not just the food resources of this country but the 

knowledge and the technical assistance that this country can provide. I think that there is enormous opportunity, as I mentioned 

earlier in my opening statement, in Afghanistan and Pakistan to 

model an effort on the part of America to empower people to be 

more self-sufficient. 

One of the problems is that most of the world farms on relatively 

small farms, and most of what we do in this country and most of 

the research that we do is focused on larger farms. I believe that 

we can provide technical assistance. I believe that we can focus our 

efforts on 1 to 2 hectare-sized farms and create an even more effective international effort to supplement what we are currently providing in the way of emergency food. 

In order for there to be food security, not only do folks have to 

be able to grow the food, not only do they have to be able to trade 

and have an economy that will allow them to trade, but there is, 

obviously, a role for emergency food assistance. 

So it is all three of those aspects. If you focus simply on one or 

two of the three, then you are not going to make the food available. 

Even if it is available, you also have to focus on creating the infrastructure, the roads, the transportation systems that allow it to get 

to people. And even if it is accessible to people, you also have to 

make sure that there is adequate information about how to properly utilize food. 

So all three of these components have to be part of what USDA 

does and what the United States does relative to food security. It 

is, in my view, not just one. I think you have to do all three, and 

I think you have to focus on all aspects of this. 

Senator BROWNBACK. Thank you. 

Senator KOHL. Thank you very much, Senator Brownback. 

Senator Pryor. 

Senator PRYOR. Thank you, Mr. Chairman. 
66 

DIRECT FARM PAYMENTS LIMITATION CAP

Let me start, if I may, with another issue. As Senator Brownback 

alluded to on his issue, you know, we fight this fight sometimes 

around here. But I do want to get your thoughts on it, and that 

is the administration’s proposal to phase out direct payments to 

farms that, I guess, have sales revenues above $500,000. Could you 

talk a little bit about that please? 

Secretary VILSACK. Senator, I think, first of all, I want to make 

it very clear that the administration, the President, myself, USDA 

understands and appreciates the important role that the safety net 

provides in rural America. That is the reason why we moved rapidly with the preceding administration and our administration to 

implement the farm bill rules as it relates to direct payments and 

counter-cyclical payments, why we have proposed the rules relating 

to ACRE and extended the sign-up for the ACRE program, and 

why we are currently working very hard and hopefully in the next 

30 days to be able to put some of the livestock disaster payment 

rules out and to be in a position to have SURE, the disaster program, available in the fall. 

It is also one of the reasons why we do support reform but understand the important role that crop insurance plays in creating that 

safety net. So there is a commitment to the safety net. 

The proposal relates to a relatively small percent, 3 percent, of 

the farmers who essentially receive 30 percent of the benefits. 

There may be and there probably are better ways to do this, Senator, and we are happy to work with you. 

We were challenged to focus on the priorities of increasing funding for child nutrition so we could end childhood hunger in this 

country and address the obesity issue at the same time. We were 

compelled, and I think appropriately so, to also take a look at the 

bottom line. We tried to respond to the priorities, made a proposal, 

but are certainly willing to work with you. If there is a better way 

to do this, we are certainly open to it. 

Senator PRYOR. Well, I look forward to that. I think one of the 

things we should look at is the cost involved in producing the product and getting it out to the market because that varies widely depending on the product you are growing and also what region of 

the country you happen to be farming in. So I look forward to 

working with you on that. If we can do that fairly soon, that would 

be great. 

POULTRY IMPORTS FROM CHINA

My second question deals with trade, specifically trade with 

China and even more specifically with poultry. There is an amendment that was attached to the fiscal year omnibus appropriation 

bill section 727. Are you familiar with that? 

Secretary VILSACK. Yes, sir. 

Senator PRYOR. What is your opinion on section 727? And I guess 

more specifically, it seems to me that—well, anyway, I would like 

to hear your opinion on that. 

Secretary VILSACK. Well, I think it is fair to say that the opinion 

of USDA is that we are, obviously, very interested in a sciencebased and rule-based trading system. That is one of the reasons 
67 

why we have expressed concern recently on the H1N1 circumstance 

and some of the decisions that countries have made to ban pork 

products. 

Having said that, we understand and appreciate the importance 

of concerns that are expressed in Congress and throughout the 

country about food safety relative to imported food. So what we are 

doing now is we are working with Members of Congress and a 

number of other folks to try to figure out precisely what the concerns are and see ways in which USDA can specifically respond to 

those concerns as quickly as possible so that whatever barriers 

exist can be removed and we can open up as much trade in all 

products as quickly as we possibly can. 

The commitment to you and to this Congress and to this committee is to work as quickly as we can to figure out precisely what 

we can do better than we are currently doing, and I think, hopefully, we will, within the next several months, have a better, clearer understanding of precisely what we can do better. Once we know 

that, we are committed to making that happen. 

Senator PRYOR. Great. That is music to my ears. I would love to 

be part of those discussions with you and try to figure out how we 

can proceed from here. My impression of section 727 is it ends up 

hurting American agriculture, specifically the poultry part of that. 

But we can talk about that more offline and have more discussions. 

RESEARCH FUNDING AT LAND GRANT UNIVERSITIES

The last question I have for you is about the traditional land 

grant colleges and the research that is being done there. I believe 

it was Senator Brownback—I am sorry—Senator Bond—one of 

those two referred to that. Could you tell us about the funding 

there? There is a core element of that research. Then there are a 

lot of other things that get done. Could you tell us about your vision for how we should prioritize those research dollars? 

Secretary VILSACK. Thank you for that question. And I certainly 

appreciated Senator Bond’s comments, and I understand his concerns. 

Let me simply say, alluding to the fact that we had a relatively 

short period of time to put this budget together, that I did not feel 

comfortable knowing fully and completely all aspects of the Department’s activities. So what I decided to do was in hiring the Under 

Secretary for Research, Education, and Economics to challenge and 

to charge Dr. Shah, recently confirmed by the Senate, to take a 

look at all of our research activities to make sure that we properly 

prioritize, we properly fund, we properly understand the intersection of those research opportunities at USDA and at the land grant 

universities and the private sector so that we can make sure that 

we are spending and investing our resources as wisely as possible. 

Only then would I feel comfortable in terms of committing to a 

budget of additional resources or different resources directed in a 

different way. 

I understand the importance of research. I clearly understand 

the importance of land grant universities. I worked at one before 

I came here. I worked on the Seed Center at Iowa State University, 

and I understand precisely the work that it does and that land 

grant universities throughout the country do. 
68 

I will tell you that in discussions with the Afghan and Pakistani 

minister, the one topic that came up repeatedly was the Extension 

Service, the important role that extension plays. They would like 

to be able to replicate that in their countries. 

So I do understand it. I would just like to have the opportunity 

to better understand the details and the specifics and to be able to 

prioritize appropriately so that I could then be able to justify precisely what we are doing and why we are doing it. 

Senator PRYOR. Thank you. 

Thank you, Mr. Chairman. 

Senator KOHL. Thank you very much, Senator Pryor. 

Senator Cochran. 

2008 FARM BILL PROVISIONS

Senator COCHRAN. Mr. Chairman, thank you. I find myself in 

agreement with the distinguished Senator from Arkansas about the 

possible implications with changes in the farm bill or administration actions with respect to implementing the farm bill that might 

make it more and more difficult for southern agriculture producers 

along the Mississippi River where traditionally the crops have been 

cotton and rice and, to some extent, soybeans and others, that they 

will likely suffer more than any other segment of agriculture if this 

administration’s proposals are actually codified by the Congress. 

So I just mention that. You know it already, but it is a serious 

concern. It could likely lead to support for cap and trade legislation. I never have understood exactly why we have that language 

to describe that legislation, but it is going to reduce prices paid to 

farmers. It is likely to increase input costs as well. I do not know 

who benefits from that except those who want major changes made 

in the farm bill. 

We spent a year in hearings and working to try to develop a consensus for writing a new farm bill, and now to have this administration come in and immediately start attacking major provisions 

that were the objects of a lot of debate and a lot of difficulties in 

getting included in the bill set aside, I am concerned about that. 

I hope that we will support the administration’s efforts in developing more aggressive trade policies. We think that is a very important step in the right direction, and we encourage you to use the 

tools that Congress has placed in the farm bills in the past that 

have worked, and we hope you can be successful in increasing our 

share of world markets with the use of those provisions. 

DIRECT FARM PAYMENTS LIMITATION CAP

Let me ask you if you could give us an update on the Department’s farm bill implementation activities with respect to payment 

limitations. 

Secretary VILSACK. Senator, the direct payment and counter-cyclical rules are out. The ACRE rules are out. The time period for 

sign-up is extended to August 14 to give folks the capacity to determine what is in their best interest. So those rules are out, and we 

are waiting for farmers across the country to make decisions which 

are important to their operations. Once those decisions are made, 

we will certainly honor them. 
69 

We are also in the process, this month, of working diligently with 

OMB to try to complete work on a number of the disaster provisions, particularly as it relates to livestock. We know the circumstances particularly in the upper Midwest and other parts of 

the country with reference to livestock and storms and the impact 

of floods. So we are working very hard to get those rules out so people understand how they can sign up. 

SUPPLEMENTAL REVENUE ASSISTANCE PROGRAM

We also appreciate the SURE program, which was part of the 

2008 farm bill, a new disaster program. It is a complex program 

to develop, made more so by the changes that were made to it as 

a result of the American Recovery and Reinvestment Act. It is also 

highly tied to the technology challenges that we have within the 

USDA. Operating with very antiquated technology and software, it 

sometimes becomes very cumbersome and time-consuming to write 

the software to implement these programs. But we believe we are 

on track to have SURE rules out, at least in some form, in the fall. 

Then we will have to collect data concerning losses and hopefully 

we will be in a position to respond with payments in the following 

year. 

Senator COCHRAN. Thank you very much. 

Senator KOHL. Thank you, Senator Cochran. 

Senator Johnson. 

NATIONAL ANIMAL IDENTIFICATION SYSTEM

Senator JOHNSON. Thank you, Secretary Vilsack, for conducting 

an animal ID listening session in South Dakota. Are there any 

parts of the current plan you are absolutely committed to moving 

forward? 

Secretary VILSACK. Senator, this is, among many issues, a very 

contentious and difficult one. It not only creates different attitudes 

in different parts of the country, it creates different attitudes within the livestock family generally, poultry and pork having different 

views about it than cattle, and within the cattle industry, different 

views depending upon whether you graze on public lands or private 

lands or a combination. 

We have not completed the listening sessions, and so the candid 

answer to your question is I have not made any specific decisions 

relative to the program and improvements to the program because 

I want to give everyone an opportunity to have input. 

I will say that the reason why we are doing these listening sessions is because there has been concern expressed by some Members of Congress about whether or not the investment that is being 

made today by the Federal Government, now in excess of $130 million, is money well spent. That concerns me from a market standpoint. A recent study suggested that one incident could cause the 

livestock industry as much as $13 billion in losses. We know one 

head of cattle coming across the border from Canada caused us significant problems in our cattle which we still yet have to recover 

from in terms of our trading partners, and we also know that our 

trading partners are looking very closely at the safety and security 

systems that we have. 
70 

There have been a number of concerns that have been raised, 

which I am sensitive to. One is the cost. Two is the technology, 

whether or not the Government is going to address a specific technology or a range of technologies that could be used. Three, obviously, whether it is voluntary or mandatory. Four, who bears the 

cost? There is a significant difference between cattle, pork, and 

poultry in terms of the overall cost to the industry. And there are 

deep concerns about who gets the information, who uses it, how is 

it accessed, and whether the public through the media would have 

the capacity through the Freedom of Information Act to access information. All of those issues and I suspect a whole lot more have 

been identified, as we look for improvements, we are going to have 

to think creatively and innovatively about. 

Senator JOHNSON. Could you provide me with a timeline on all 

this to take place and when your decisions will be made? 

Secretary VILSACK. Well, we expect and anticipate that it will 

take another month to two to complete the listening sessions, and 

then, hopefully, not very long after that, we would be in a position 

to make some recommendations and suggestions to see what reaction we get. 

The one thing I do not want to have happen is I do not want this 

Congress to lose confidence in the system, not provide funding, and 

then send I think what would be a very poor message to our trading partners and would, I think, negatively potentially affect our 

trading opportunities. 

COUNTRY OF ORIGIN LABELING

Senator JOHNSON. Given your excellent dedication to the COOL 

program, how have you been working with the USTR to ensure 

COOL is implemented properly? 

Secretary VILSACK. We have had very good conversations with 

Ambassador Kirk and his staff. We have had two face-to-face meetings between USDA staff and the Trade Representative’s staff. I 

appreciate the working relationship that we have developed. Ambassador Kirk and I were friends before we had this opportunity 

in the administration, and we have built on that friendship. 

We continue to provide information and resources concerning 

COOL to the Trade Representative so that there is a clear understanding and appreciation that we are committed to COOL. We are 

committed to following the intent of Congress, as you all have outlined it, that we do not think that what we have proposed or suggested or that what you all have passed is necessarily trade-distorting. We think it is within the guidelines provided by the WTO. 

We know that our trading partners may have disagreements about 

that. 

Just one observation. A recent report suggested that livestock activities in Canada have been a bit more robust than they have been 

in this country, which would suggest that perhaps COOL is not 

having the impact or effect that some might believe. 

We will continue to work with USTR, continue to work with our 

Canadian and Mexican friends to make sure that they fully understand what this is and more importantly what it is not. 
71 

DIRECT FARM PAYMENTS LIMITATION CAP

Senator JOHNSON. I have been an enthusiastic supporter of a cap 

on $250,000 for a payment limitations cap. But I am concerned 

about the $500,000 gross sales limit approach for direct payments 

also included in the budget. I want to point out that I am in favor 

of the $250,000 cap, unlike some of my colleagues, but I am opposed to the sales revenue cap because it is a gross number and 

not net. 

Secretary VILSACK. Well, Senator, in one respect I guess the 

USDA can be congratulated for developing such a strong bipartisan 

reaction to this idea. When I was Governor of Iowa, I often said 

that I would propose but the legislature would perfect, and I suspect that that strategy is in play here. 

Senator JOHNSON. Where do you propose to have an offset for the 

change if we make it? 

Secretary VILSACK. Well, Senator, we are pledged to working 

with you, with this committee, and with your counterparts in the 

House to make sure that this budget squares itself. We are committed to working with you. We were sure of one thing when we 

proposed this budget that you all would not just say, well, this is 

great, all in favor, say aye. You would have a lot to say about this 

budget. We are committed to working with you. 

I think it is important for me to reemphasize the priorities that 

the President has and that I share. We think it is important for 

a multitude of reasons that we address aggressively child nutrition. 

We think it is important for a variety of reasons, not to mention 

national security and economic security, that we continue to invest 

in bioenergy and rural development. And we do believe that there 

are ways in which we can have a strong, adequate safety net, as 

perhaps you have suggested with the cap, that do not necessarily 

make it more difficult for people to survive. And we are committed 

to that set of priorities. 

Senator JOHNSON. Thank you, Mr. Secretary. 

Senator KOHL. Thank you very much, Senator Johnson. 

Senator Bond. 

Senator BOND. Thank you, Mr. Chairman. 

Mr. Secretary, being a fellow former Governor, we have had a lot 

of experience on the legislative branch disposing of what we have 

proposed. 

I appreciate your answers to my colleague from Arkansas on research. We want to work with you on that. 

When you were speaking about Afghanistan, agriculture there, 

we have talked about the National Guard ag development teams, 

and we want to work it to the point where USDA is participating 

as security advances on that area because there is a tremendous 

opportunity. 

CHILDHOOD OBESITY

I want to move into another area. In one of the answers to one 

of the questions, you mentioned the priority of dealing with obesity, 

and you also testified initially about serving very nutritious food. 

As you know, the SNAP program is getting a $7.3 billion increase 

to over $61 billion, and we are all aware that this extra investment 
72 

in taxpayer money can legally be used to buy sugar-sweetened 

drinks and empty-calorie food. 

Now, I am concerned. Are we doing well by taxpayers but, most 

importantly, by the recipients of assistance and their families when 

we subsidize poor and unhealthy diets? It seems to me that there 

is an opportunity with the electronic benefits card and point-of-sale 

displays or information to make sure that more of the assistance 

that is received is used in the healthy pyramid food type purchases. 

What are your views on that? 

Secretary VILSACK. Well, Senator, first of all, I want to acknowledge that you feel very strongly about this, and I appreciate the 

passion that you have about this. We have talked about it in your 

office and I know that you are committed to it. 

Let me, first and foremost, say that food is an extraordinarily 

complicated set of issues. Until I got this job, I did not realize that 

there were over 300,000 food products sold in grocery stores around 

this country, and that over 12,000 new products were introduced 

in the last 10 or 15 years. 

We have made a concerted effort to, one, work diligently to try 

to improve the food pyramid so that it reflects modern science; two, 

that we do a much better job of promoting through educational 

tools the need for more nutritious food. We have begun a process 

of working particularly focusing on young children and young families to assure that moms and dads are aware of the important responsibility they have in making choices for their children. We are 

committed to working with our schools to make sure that not only 

are the school lunches and school breakfasts more nutritious, but 

what is in our vending machines at schools reflects that same attitude. So we think we are aggressively pursuing an education effort, 

and we think that over time it will make a difference. 

Senator BOND. But you are not willing to go down the road with 

me and cause a little bit of firestorm. I understand that. 

AGROFORESTRY RESEARCH

In the time I have remaining, we have had an opportunity to discuss agroforestry which is done—I am sorry my colleague from Arkansas has left. The University of Missouri School of Agroforestry 

works with the Booneville Agroforestry. It is a regional approach 

to assisting agriculture and particularly small farmers in using 

plants and trees for environmental benefits, providing better income. We are developing new crops like, I might just mention, 

chestnuts for example, as a second source of income. I had a minimum amount of happiness when I understand that the money for 

Booneville had been proposed for rescission. I hope that you all will 

consider that. 

But most importantly, I hope that we will have an opportunity 

to work with you and your staff with people who are interested 

here in Washington about the opportunities we have to do so many 

of the things you are talking about through agroforestry research. 

Secretary VILSACK. Senator, we are excited about the opportunities that forests present. As I explained earlier in my opening 

statement, we see a new opportunity for us to link our forests with 

our private working lands with our urban centers so that there is 
73 

a full appreciation across the country of what trees and forests 

mean. 

I know that there are concerns about specific proposals relative 

to things that you all designate and specify. Again, I think it is a 

reflection of the budget process. We will certainly work with folks, 

but please do not take from whatever we propose the belief that we 

do not understand and appreciate the importance of forests because 

we do. We are very excited about what we see as a new day for 

the U.S. Forest Service and NRCS and linking those two important 

components of USDA to all of America. 

Senator BOND. Well, I thank you for that. We will look forward 

to working with you. I also appreciate your work and the discussions we have had on biotechnology, a complicated area. We will 

discuss that later. 

Thank you, Mr. Chairman, and Mr. Secretary, thank you. We 

have got a lot of exciting and interesting things to work on. 

Senator KOHL. Thank you very much, Senator Bond. 

Senator Nelson. 

Senator NELSON. Thank you very much, Mr. Chairman. Thank 

you for holding this hearing. 

RECOVERY ACT BROADBAND PROGRAM

Mr. Secretary, welcome. Let me first say as both former Governors from rural States, neighboring States, we learned about the 

importance of communication extending out to the rural areas into 

farmsteads and to small schools, as well as to the major metropolitan areas. 

As we set forth in the stimulus package for broadband deployment, it is my understanding that there may have been some slowdown, not necessarily intentionally, but as a result of trying to establish rules to move forward with the distribution of money to expand that broadband deployment. Knowing that the construction 

season is a little bit earlier for our States than it may be for some 

of the other States that do not enjoy the cold weather, is there anything that can be done to move the development of some of those 

rules along maybe a little bit more quickly? 

Secretary VILSACK. Senator, we have been working very closely 

with Secretary Locke and his team at Commerce. We are confident 

that by the end of this month we will have an outline of rules and 

regulations relative to how folks might be able to qualify for the 

grants and loans under the broadband program that you all have 

put into the Recovery and Reinvestment Act, and we anticipate 

that the first set of resources will go out in probably one of three 

different deliveries in the fall of this year. So we are aggressively 

working to get that done. We appreciate the importance of distance 

learning, of telemedicine. 

But I would also suggest to you that it is an extremely important 

strategy for rural development in terms of economic development. 

Small businesses currently that have a unique service or product 

are able to perhaps sell locally, but with broadband, they may be 

able to expand their market globally. This is part of the wealth creation strategy that we are trying to implement at USDA. So we are 

very cognizant. We are moving forward. 
74 

And I would say we are also moving in a streamlined way. We 

will not have separate applications. We will have a single application, single process. We will make it as easy as possible for folks 

to apply for these resources. 

Senator NELSON. That is very encouraging because I was concerned where you have a couple of agencies trying to work together, that there might be some bifurcation as opposed to unification of the process. So that is extremely encouraging. 

DIRECT FARM PAYMENTS LIMITATION CAP

The discussion earlier from my colleague from Arkansas, Senator 

Pryor, regarding the payment limitations issue—I am concerned 

that what has been proposed by the administration on two occasions, the $500,000 direct payment limitation is not appropriate. I 

look forward to being able to work with you to design something 

more in line with what Senator Johnson and Senator Grassley and 

others have done in the past to try to limit the direct payments to 

large farm and ranching operations that just simply do not require 

the same kind of assistance from time to time or the same kind of 

a safety net that you would expect for smaller farms to be able to 

protect and keep agriculture from becoming all mega-farms. So I 

hope that we can look forward to working together on that. 

Secretary VILSACK. You have my commitment to do that, Senator. 

NATIONAL DROUGHT MITIGATION CENTER

Senator NELSON. The final question I have deals with water. The 

University of Nebraska in Lincoln has been established as the base 

for watching water management but also in predicting drought. 

The National Drought Mitigation Center provides a lot of background and data on drought, including what is now referred to as 

and cited as the drought monitor. One of the reasons that we focused on that and perhaps one of the reasons why it is housed in 

Nebraska is that now, according to the Ag Census of 2007 by your 

agency, Nebraska is the number one irrigating State based on acreage. 

What we have determined is that you cannot, obviously, prevent 

drought. You cannot necessarily always predict drought. But the 

more data that you have on drought, the better you are able to predict and prevent against some of the most adverse consequences of 

drought, in other words, changing the mix of crops that are used 

or changing the approach to agriculture during a period of dryness. 

I hope that the USDA sees this as a valuable tool for agriculture 

in those areas that are most directly affected by continuing dry periods. The old saying I think is true. When you are in the middle 

of a drought and it rains, the question is whether that is the end 

of the drought or the beginning of the next drought. So I am hopeful that there will be a lot of support for the efforts in the National 

Drought Mitigation Center. 

Secretary VILSACK. Well, Senator, thank you for those comments. 

We are acutely aware of the growing concern about water generally 

and see that there are a number of different strategies that we 

need to focus on in addition to those that you have identified. 
75 

Just yesterday I had the opportunity to visit with the CEO of a 

seed company. They are, obviously, working very diligently on seed 

technology that might result in drought-resistant crops. That would 

certainly be helpful. 

Interestingly enough, I would expect that we will learn, even 

more than we already know, about these issues in terms of our 

work overseas. In meeting with the Afghan and Pakistani ag ministers, one of the big concerns they have is water and proper irrigation techniques. So I think there are a wide variety of ways in 

which we need to address this holistically and comprehensively. 

Senator NELSON. Thank you. 

Thank you, Mr. Chairman. 

Senator KOHL. Thank you so much, Senator Nelson. 

Senator Bennett. 

Senator BENNETT. Thank you, Mr. Chairman. 

Mr. Secretary, welcome and thank you for your service, your willingness to put up with all of this, having been in charge for a 

while. Now you are discovering that nobody is in charge. 

Secretary VILSACK. I thought you were, Senator. 

Senator BENNETT. Sometimes we think we are. 

RECOVERY ACT BROADBAND PROGRAM

Senator Nelson has covered most of the items that I wanted to 

cover with respect to broadband, and I am delighted that you are 

as committed as you are to pushing this forward. Let us just drill 

a little deeper into your methodology of trying to get the money out 

to the rural areas. 

I understand that you are hiring 40 new people with respect to 

the expanded RUS program. Is this to replace a contractor? Is this 

in addition to the contractor? Will this help get money out faster? 

Just share with us the particulars of how that is all going to work. 

Secretary VILSACK. Senator, as you know, USDA has been criticized in the past for the way in which it has handled some of these 

resources in rural communities. We are sensitive to those criticisms 

and want to respond to those criticisms and want to make sure 

when you all invest in us one more opportunity to promote 

broadband access in unserved rural areas that we actually deliver. 

So this is a decision on our part to try to make sure that we have 

sufficient outreach and sufficient information and sufficient evaluation to actually get the job done properly. 

I would also say that you have given us parameters, suggesting 

that at least 75 percent of what we have available from the Recovery and Reinvestment Act needs to be focused on these unserved 

rural areas. 

Senator BENNETT. Right. 

Secretary VILSACK. And that is the intent. I come from a State, 

when I was Governor, where we made a really concerted effort to 

advance this technology without identifying which specific technology we would use. There are many options and it depends on 

what part of the country you are in. It depends on what has already been done. It depends on whether or not you are talking 

about funding the last mile, the middle mile, precisely what you 

are going to do. I think what you will see from us is a comprehensive approach. In some parts of the country, a middle mile is more 
76 

important for us to finance than the last mile. In some parts of the 

country, it may be that the last mile is most important. It may be 

that we work with private contractors. It may be that we work 

with cities and communities. It may be that we are working with 

an individual locality or a group of localities. 

So there is no one-size-fits-all, and so you really have to have a 

lot of people working diligently to make sure that you are making 

the right set of decisions. We are going to work very hard to make 

that happen. We do not want to be subject to the same criticisms, 

appropriately so, that we have been in the past. 

Senator BENNETT. Thank you. 

COUNTRY OF ORIGIN LABELING

Let me switch to another issue that was raised by Senator Johnson, and that is COOL. I do not know of any one issue that has 

been more contentious in this subcommittee over the years than 

COOL. All right, you are moving forward. You are complying, et 

cetera. Do you have any ideas—or any data is a better way of putting it—as to whether or not the consumer is paying any attention? 

Is it really making any difference in the supermarket? 

Secretary VILSACK. Senator, I do not know that we have specific 

data that I would be comfortable suggesting a specific response to 

your question. I do know that we are monitoring. We will probably 

likely monitor during the fiscal year approximately 5,000 locations 

to make a determination of compliance. 

From a general proposition—this is not data-driven, but from a 

general proposition I think there is a growing appreciation in this 

country for wanting to know your farmer, wanting to know where 

your food is coming from, wanting to know more about your food. 

I think we are going to continue to see more of that. Especially as 

we focus on nutrition, especially as there is a health care debate 

in this country and prevention and wellness become critical components of that, I think you are going to see a rising awareness. 

Senator BENNETT. I agree, but I do not think personally that location is going to make any difference to a customer as to what he 

or she will buy in the supermarket. 

Secretary VILSACK. My only caveat to what would normally, I 

think, be an accurate observation on your part, I think price is obviously pretty significant. 

Senator BENNETT. Yes. 

Secretary VILSACK. We had a program called Taste of Iowa when 

I was Governor, and people kind of liked the idea of purchasing 

food that was produced in Iowa. I will tell you I found it interesting 

that Lay’s potato chips has decided to specifically identify the State 

in which the potato is coming from so that you can actually buy 

Georgia Lay’s potato chips if you are of a mind to buy Georgia 

Lay’s potato chips or Idaho. So they are giving consumer choice. 

They must be doing it because their marketing advice—— 

Senator BENNETT. That I agree with. I have always been in favor 

of voluntary COOL. It is the required Federal label that I have always doubted. If I can just share this with you, the one experience 

we have had before in this country has been the drive by the 

United Auto Workers to make sure that North American content 

would be listed on every car, and there was a great fight about that 
77 

in the Congress for a long time. Finally, the union won, and then 

a few years later, people went back and started asking customers 

if they paid any attention to it. The vast majority of customers 

said, no, we didn’t notice. But there was a small group who said, 

yes, we read the label very carefully, and if there is a high Japanese or German content, we are more likely to buy the car. So that 

did not necessarily work in the way that the sponsors of the legislation had in mind. 

Thank you, Mr. Chairman. 

Senator KOHL. Thank you, Senator Bennett. 

Senator Reed. 

Senator REED. Thank you very much, Mr. Chairman. 

RECOVERY ACT WATERSHED PROJECTS IN RHODE ISLAND

Mr. Secretary, thank you not only for being here, but this week 

you approved a commitment under the Recovery Act for four flood 

plain projects in Rhode Island, and we really appreciate it. It will 

not only get people to work, but it is critical to the homes along 

the Pawcatuck River, part of this watershed. At this moment, the 

Natural Resources Conservation Service is completing their overall 

watershed plan, and it should be before you very quickly. I would 

ask for your expeditious and, in the same spirit that you used this 

week, approval of the plan. Thank you very much. 

Secretary VILSACK. Yes, Senator. 

Senator REED. It is more of a thank you than anything else. 

Secretary VILSACK. I made a note of that. 

Senator REED. If it’s the first one today, then—— 

Secretary VILSACK. I am sure it is not. It better not be. 

Senator REED. It better not be. 

WILDLIFE HABITAT INCENTIVES PROGRAM

There is one program that has been very useful to my State. It 

is the Wildlife Habitat Incentives Program, the WHIP program, 

and it has been significantly reduced in the budget. It is about a 

50 percent cut. I recognize you have to make very difficult decisions. 

But the other aspect of this is that through changes in the last 

agricultural bill and through limited funding, it has posed real 

practical problems to use in Rhode Island. We have been very successful in removing old dams that are part of our industrial history. The whole Industrial Revolution began up in Rhode Island 

with the Slater Mill. But taking those dams out allows the fish to 

begin to propagate again. We have done it generally through partnerships with the State and not-for-profits. Also, it has been made 

possible because the NRCS has been able to put up-front cost in 

place. 

The changes in the legislation, the cap on annual contract payments, that limit their ability to put money up front and also restricting sort of who can participate with them is a problem. I understand this is an issue that is both an authorization and appropriations issue. But I wondered if you could give some thought to 

ways in which other programs might be available, other methods 

might be used to continue to help us in Rhode Island to restore 

these riverways and restore fish to the riverways. 
78 

Secretary VILSACK. Senator, that is a challenge that we will take 

up. If I might, I think it is necessary for me to respond to where 

we are headed in terms of conservation. 

The overall budget relative to conservation, at least from our per- spective, will result in a total of $4.7 billion being committed in a 

variety of programs, both in technical and financial assistance. 

This is a $374 million increase over the 2009 level and a $744 million increase over 2008. 

What we attempted to do—and we have asked, I guess, some understanding on the part of this committee and the Congress—was 

to try to match up as best we could the resources in individual programs with what we see as the historical need and desire for those 

programs, together with the fact that with the new program, the 

Conservation Stewardship Program, we have some things to learn 

about how best to implement, how complicated or easy it will become. So we made our best-guess estimate on a relatively short 

time frame about how best to do this. 

But there is no question there is a commitment to private working lands. There is no question there is a commitment to trying to 

figure out how to help landowners, property owners protect their 

land. There is no question that we understand the significant role 

that these programs can play in providing that protection, and we 

are committed to it. As I said earlier, what we hope to be able to 

do is to integrate it with what we are doing with the Forest Service 

in other parts of the country to preserve water, both quality and 

quantity of water. So we are committed. 

Let me also say that I have not had an opportunity yet to institute this, but we have just begun starting a process of taking a look 

at how we make decisions and whether or not there are ways in 

which we can streamline, reduce the steps necessary in making decisions without reducing the appropriateness or the correctness of 

the decision we make. I cannot tell you that that is going to be 

done tomorrow, but I can tell you that it will be done, and hopefully some of these programs will be easier to administer and easier to understand than they have been. 

Senator REED. Well, thank you, Mr. Secretary. Just a quick 

point. You have a national mandate, and some of these programs 

are particularly useful in some parts of the country and we found 

this with the WHIP program because we are trying to really reverse hundreds of years of industrial use along our rivers, and that 

is not the same challenge in many parts of the country. So any help 

you could give along these lines, we would appreciate. Thank you, 

Mr. Secretary. 

Thank you, Mr. Chairman. 

Senator KOHL. Thank you, Senator Reed. 

Senator Harkin. 

Senator HARKIN. Mr. Chairman, thank you very much and, 

Ranking Member Brownback, thank you for your great stewardship 

of this committee and also for having this hearing today. 

I am sorry I am late, Mr. Secretary, but I was chairing a hearing 

on the authorizing committee on derivatives. And we had Mr. 

Gensler, the new head of the Commodity Futures Trading Commission, and it went on for a long time. So I apologize for being a little 

bit late. 
79 

STATEMENT OF SENATOR TOM HARKIN

Mr. Chairman I hope, that you and other members of the committee are now getting to know the Tom Vilsack that those of us 

in Iowa have known for a long time, a very dynamic, smart, and 

progressive leader who is not afraid of change. As government and 

a State Senator he has shown that he has the requisite managerial 

expertise to guide and direct change for very positive ends and I 

am certain he will continue that as secretary of agriculture. 

Three areas in which I note that you have been such a great 

leader on just since you have taken over down there, Mr. Secretary, 

are your great leadership, on renewable energy, which trails what 

you did as Governor of Iowa; your leadership, of course, on nutrition and looking ahead on that. We have to reauthorize our child 

nutrition bill this year, and we look for your and Deputy Secretary 

Merrigan’s help and input on getting that through. 

I do want to commend you and the President for putting that 

extra billion dollars a year in the President’s budget request for 

child nutrition programs. This funding is vitally important. It is my 

belief that we need to get better food for our kids in schools, such 

as fresh fruits and vegetables, and meats. Well, those may cost a 

little more money, but if we really want our kids to eat well, we 

are going to have to provide the needed funding. So I am really 

glad that you have put in your budget an extra billion dollars a 

year for child nutrition programs. 

Secretary Vilsack, I would also like to mention your leadership 

in conservation and I civil rights since being confirmed you have 

taken the bull by the horns on civil rights, and I congratulate you 

for that and ask that you do not let up in addressing civil rights 

concerns at the department. 

PREPARED STATEMENT

I want to thank you and Deputy Secretary Merrigan both for 

your great leadership at the Department. 

Mr. Chairman, I ask that my full statement be made a part of 

the record. 

Senator KOHL. We will do that. 

[The statement follows:] 

PREPARED STATEMENT OF SENATOR TOM HARKIN

Thank you, Chairman Kohl and Ranking Member Brownback, for holding this 

timely hearing on the President’s fiscal year 2010 budget proposal for the U.S Department of Agriculture. 

I welcome Secretary Vilsack back to the subcommittee. I have always known that 

he is deeply committed to farm families, rural economic development, and strong 

Federal nutrition programs. But, in his first months in office, he has really been 

a breath of fresh air here in Washington. Secretary Vilsack has charted an ambitious, reform agenda for the Department. And I look forward to continuing to support him in every way I can. 

As we all know, our economy continues to face extraordinary challenges. The 

downturn has taken its toll on farm country, and it is also placing an enormous 

strain on our Federal nutrition programs. But farmers and ranchers are a great 

strength of this economy. And I am confident that they will help lead the way to 

recovery. 

The President’s fiscal year 2010 budget proposal for USDA builds on investments 

made by the 2008 farm bill, the fiscal year 2009 Omnibus Appropriations bill, and 

American Recovery and Reinvestment Act of 2009. Together, these bills are putting 

people to work, supporting our agricultural producers, and spurring rural economic 
80 

development. I appreciate that the President’s budget proposal is the product of 

tough choices during difficult times. 

Mr. Secretary, you and I share President Obama’s vision of transforming America’s energy future by vastly expanding our reliance on domestically produced, renewable energy. I was pleased to see that the President’s budget builds strongly on 

investments made USDA energy programs in the 2008 farm bill. The President’s 

budget request, along with mandatory funding provided in the farm bill, will accelerate the development and commercialization of advanced biofuels and other forms 

of alternative energy. 

In addition, I enthusiastically welcome the President’s request for $1 billion annually in new funding for Federal child nutrition programs, including the School 

Lunch and Breakfast Programs, the Summer Food Service Program, and the Child 

and Adult Care Food Program. These are enormously effective programs, but they 

are under great strain, right now, because of the recession. 

We need more aggressive efforts to ensure that that all eligible children are receiving the benefits to which they are entitled under the law. This is especially important as we seek to make good on President Obama’s commitment to end childhood hunger in America by 2015. 

I commend the administration for giving strong priority to child nutrition programs in the proposed budget. As a member of this subcommittee and as Chairman 

of the Senate Committee on Agriculture, Nutrition, and Forestry, I look forward to 

working with the Secretary to pass a strong, reform-minded reauthorization of our 

child nutrition programs. 

On a less positive note, I am very disappointed with the amount allocated in the 

President’s budget for conservation programs. The 2008 farm bill—which passsed by 

overwhelming bipartisan margins in Congress less than a year ago—authorized significant new investments to promote conservation and sustainable use of our natural resources. 

I worked hard to include a robust conservation title. In my view, these programs 

are now more important than ever, especially as we work to address significant environmental concerns like climate change, nutrient runoff, loss of wildlife habitat 

and biodiversity, and loss of critical wetlands. 

I hope that the Chairman and Ranking Member, along with other members of this 

subcommittee, will work with me to maintain the investments provided in the farm 

bill for conservation programs. 

Again, I thank the Chairman and Ranking Member for holding this hearing. And 

I look forward to the Secretary’s testimony. Thank you. 

Senator HARKIN. I have a few questions I will submit in writing, 

but do have a question I would like to ask you. 

WRP 2008 FARM BILL PROGRAM

During the last farm bill we fought very hard for conservation 

funding. This was a long, drawn-out negotiation both in the Senate 

and then in conference. We reached compromises. As I have often 

said, the farm bill was not exactly the bill that I would have written, and I think everybody on the Senate and House Agriculture 

Committee’s would say the same thing. Everybody had to make 

compromises. 

But, in the end we were able to keep a very strong conservation 

title in the 2008 farm bill. I am a little concerned, I must note for 

the record, about the proposed cutbacks in the WRP program and 

the EQIP program in the budget proposal. As far as I have been 

able to discern, there has been no reduction in the requests for assistance under programs like WRP or EQIP. Again, with increasing 

demand for food, feed and now moving more toward renewable energy and using land for that purpose, it may well entail more intensive cropping and demands on resources and we are going to 

need more conservation practices on the land. 

I am glad to see that you have kept the mandatory funding levels 

for other programs like the CRP and CSP. But, I am concerned 
81 

about the WRP. Can you just give me some idea of why that funding was cut back? 

Secretary VILSACK. Senator, first of all, I am keenly aware of 

your personal commitment to conservation and the work that you 

did not just on the 2008 farm bill, but also the 2002 farm bill to 

really introduce this topic of conservation in a meaningful way and 

creating private working lands conservation concepts in the farm 

bill. We are certainly supportive. 

This may not be an acceptable response to your question, but it 

is the response that I must give, and that is, we have overall increased the spending levels over what we spent last year and the 

year before in conservation generally. 

Senator HARKIN. That is true. 

Secretary VILSACK. And we have tried in many of the programs 

to match the amount of money that we are asking for with the 

amount of work that we, in fact, have been able to do. In other 

words, even though you may have authorized a substantially greater amount, the capacity of USDA in some of these programs is limited by the number of people we have that are processing these applications, making sure that they are processed accurately. 

In response to Senator Reed’s question, I have not had an opportunity yet to really focus in on the process that we are using to determine whether or not it can be streamlined and maybe as a result, we can actually process more with the same number of people 

and maybe do a better job in the future of meeting those authorized limits as opposed to what we are currently proposing. 

But the reason we are proposing what we are proposing is we 

think it is a realistic in many cases—in some cases it is actually 

an increase over what we spent last year. We think it is a realistic 

target in terms of our capacity to actually process the work. 

Senator HARKIN. Thank you. 

Secretary VILSACK. I do know this. I know that folks are working 

hard over there at NRCS and all the other agencies of USDA, but 

my guess is that there are probably some things we could do from 

a streamlined process. Senator Brownback suggested in rural development the need to integrate programs, and I think he may 

have a good point. There may be process integration that could 

take place as well. I just have not had a chance to get to that yet. 

Senator HARKIN. I appreciate that. I support streamlining that 

could be done over there. 

Mr. Chairman is my time expired? 

Senator KOHL. Go ahead. 

Senator HARKIN. Thanks, Mr. Chairman. 

RECOVERY ACT BUSINESS AND INDUSTRY LOANS

The Recovery Act money for the business and industry loans program. Would you tell me the status of obligating this funding? It 

has to be obligated by September of next year. 

Secretary VILSACK. Senator, I think we have done a reasonably 

good job of getting a significant amount of the Recovery and Reinvestment Act money out. We were fortunate because in most cases 

you were funding existing programs and we could work through 

the existing structure. 
82 

There is a funnel that is created, as you well know, between the 

vast number of people at USDA that are working on proposals that 

ultimately have to be approved by OMB, and that funnels into a 

relatively small hardworking outfit over at OMB. 

We have put a priority on some of these programs because we 

think it would create the biggest bang for the buck and the 

quickest bang for the buck. The B&I piece of this we are working 

on. We have proposals at OMB I believe, that will allow us to proceed forward with those programs in the very near future, but the 

vast majority of the rest of the money has actually been obligated 

or is out the door or is in the process of very quickly being obligated. 

I am pleased with what we have done in terms of 37,000 home 

loans. I am pleased with what we have done in terms of all of the 

direct operating loans that have been obligated. I am pleased that 

most of the watershed rehabilitation money has been allocated and 

the watershed easements have been allocated. I am pleased that 

we were able to get the SNAP money out and the administrative 

money to the States and the emergency funding and the school 

lunch monies out to the States. So we have been working pretty 

hard. B&I comes next, and I am anticipating that will be very, very 

soon. 

Senator HARKIN. Very good. 

Thank you very much, Mr. Chairman. 

Senator KOHL. Thanks a lot, Senator Harkin. 

Senator Specter. 

Senator SPECTER. Thank you, Mr. Chairman. 

Mr. Secretary, I join my colleagues in welcoming you here, and 

thank you for taking on this tough job. 

PHILADELPHIA SCHOOL LUNCH PROGRAM

A couple of subjects that I would like to discuss with you in the 

short time allotted here. Milk prices. 

I begin with the Philadelphia school lunch program, which I see 

you nodding in the affirmative on familiarity because there has 

been a very strong push by many Members on both the House and 

Senate side on this very important program which feeds children 

at 204 schools. In a big city like Philadelphia, that is a very difficult situation, a lot of single-parent families, a lot of working 

mothers, in the economic crunch we are in at the present time, 

very little income to buy the necessities of life. Where we have seen 

so many situations where children go to school hungry, no breakfast and no lunch, the educational opportunities are very limited. 

That kind of a district has been the recipient of a lot of attention 

over the years, attention on a program called Gear Up, especially 

attuned to at-risk young people, extensive job training programs, a 

very, very difficult situation, mentoring, where you find a tremendous movement from truancy to juvenile delinquency to crime, extraordinarily difficult. And this lunch program is really an indispensable building block on what I have seen as a city official and 

as a Senator. 

There is concern about at least waiting until the nutrition authorization bill comes up, consideration on adding an amendment 

to the Agriculture appropriations bill. But is there not some way 
83 

to extend this program to relieve a lot of angst that is gripping now 

parents and children in this very large, very difficult city population? 

Secretary VILSACK. Well, Senator, first of all, I certainly appreciate your advocacy for this program. It has been steadfast and it 

has been passionate. I know that it is a very important program 

to the city of Philadelphia. 

As you know, the Bush administration made the decision before 

I came into office, before President Obama came into office—— 

Senator SPECTER. We corrected all that. We thought we did. Or 

somebody did if not I personally. In fact, now that I think about 

it, I think I had something to do with it. 

Secretary VILSACK. This program has been extended a couple of 

times. But in December 2008, the school district was notified of the 

intention to discontinue the program. We recognized that an abrupt 

discontinuation of the program was not an appropriate way for us 

to respond to the moral challenge that you have outlined to these 

families. And we have been searching for a way in which we can 

not only continue to do what needs to be done in Philadelphia, but 

make sure that every inner city, every major city, the children of 

every working family or poor family that has the same kinds of circumstances get an opportunity to be well fed. I want to assure you 

that that is an absolute commitment of this USDA, of this President. He wants to end childhood hunger by 2015. He is committed 

to it. We are committed to it. I know you are. 

We are anxious to work with you to figure out ways in which 

that program can be a model, a pathway to a national effort that 

enables all of the children similarly situated to have the benefit of 

decent meals. So whether it is in the Reauthorization Act or after 

the Reauthorization Act, we are happy to work with you on that. 

We make that commitment today to work with you. 

Senator SPECTER. Are you saying, in effect, that there is some 

real optimism about our ability to have this program continued? 

Secretary VILSACK. I think what I would like to be able to say, 

Senator, is that I would like to see it rolled into a program that 

essentially extends those kinds of opportunities all over the country, including Philadelphia, not necessarily only Philadelphia, but 

including Philadelphia. We think that we have learned a lot from 

this program, and the question is can we figure out how to take 

what we have learned in Philadelphia and make sure that it is 

available to cities all across the country. 

Senator SPECTER. Well, if you are talking about rolling the Philadelphia program into a broader program, that is terrific. I think 

there ought to be a broader program, and my focus, obviously, necessarily is on Philadelphia. But if you think it can be rolled into 

a broader program, that would satisfactory. 

Secretary VILSACK. That is what we hope. I mean, I am from 

Pittsburgh, Senator, so we want to make sure the rest—— 

Senator SPECTER. I am equally concerned about Pittsburgh. 

And also, Secretary/Governor, about Iowa, and about children all 

across the country. 

Secretary VILSACK. As I am as well, Senator. 
84 

LOW MILK PRICES

Senator SPECTER. My time has expired and I will not ask another 

question to take more time of the subcommittee, but we will submit 

in writing the concerns I have about the reduction in milk prices, 

some 36 percent lower from January to April of this year compared 

to last year. We will ask you about what might be done under the 

MILC program or under the Dairy Export Incentive Program because the farmers of my State and I think the farmers across the 

country are in very bad shape. 

Secretary VILSACK. If the chairman would allow me 30 seconds 

to respond to—— 

Senator SPECTER. You are not restricted on time. It is only Senators who are restricted on time. The red light does not go on for 

you. 

Secretary VILSACK. I just simply want to reassure you that we 

are very concerned about the dairy situation, which is why we have 

got the MILC payments out. We anticipate that by the time it is 

all said and done—I want to make sure I get this number right— 

almost $900 million will be paid, we suspect, through the MILC 

program. 

We have also given instructions to our farm service agencies to 

work with our dairy producers to enable them to restructure, refinance, reexamine their lending so that they are not put in a difficult situation because of these low milk prices. We know that they 

are looking very carefully and closely at how they can help. 

We also recently utilized the DEIP program making sure that it 

was WTO-compliant but that we exercised support for exports as 

well. 

So we have taken a number of steps in the last couple of months, 

Senator, to respond because of your advocacy and Senator Casey’s 

advocacy and, Senator Kohl, your advocacy in particular and those 

from California. We have been listening and we have been trying 

to respond as best we can. 

Senator SPECTER. That is very encouraging. Thank you very 

much, Mr. Secretary. 

Thank you, Mr. Chairman. 

Senator KOHL. Thank you very much, Senator Specter. 

GLOBAL FOOD SECURITY

Mr. Secretary, as you know, global food security is one of the 

most important issues in this subcommittee, and we discussed a 

number of ways to improve agricultural systems in developing 

countries in order to improve stability and to also fight world hunger. How is USDA involved in this effort, and what more can you 

do to improve food security around the world? 

Secretary VILSACK. Senator, I would say a couple of things. 

First of all, we think this is an opportunity for us to expand the 

McGovern-Dole program. As I said earlier, this is a program that 

has been enormously successful. We have suggested an increase to 

$200 million. That will allow us to expand the program to four African nations, helping about 400,000 additional children. We are 

pleased with the fact, again as I said, a number of countries have 

been so impressed with the appropriateness of helping feed chil-
85 

dren and the connection that that has had with youngsters’ ability 

to be educated, that they themselves have taken up that responsibility. 

We also believe that we need to integrate our efforts with the 

State Department, with USAID, and to develop an overarching philosophy that is focused on the three principles of food security, 

which is availability, providing technical assistance and help so 

that countries can raise what they can raise and do it in the most 

productive way possible, assisting those countries in utilizing trade 

to supplement what they cannot raise and providing appropriate 

emergency food assistance when that becomes necessary. That is 

one component. 

The second component is accessibility, the ability to get food from 

where it is being grown to where it is needed. That involves infrastructure, and we are specifically, as it relates to Afghanistan and 

Pakistan, hopeful that we can work with those two countries to 

substantially increase the infrastructure, to substantially increase 

productivity, to deal with water issues, to create assistance with 

regulatory structures and frameworks so that they can enhance 

their trade opportunities as a model, and then finally utilization, 

the capacity to properly refrigerate, properly handle, properly utilize the food that is available and is accessible. All of those components have to be part of our overall program. 

USDA is prepared from technical assistance from the research 

component, from APHIS, from the regulatory assistance that we 

can provide and from the fellowships that are funded through 

USDA, the Borlaug Fellowships, the Cochran Fellowships, and the 

land grant university exchanges that take place. All of that is part 

of an overarching program that we are instituting with Afghanistan and Pakistan and we hope to be able to extend it to sub-Saharan Africa. We think if we can do this and we have the resources 

to do it, we can, I think, profoundly impact this food insecurity 

issue that challenges the world. 

And then finally, we discussed earlier today water. That is a very 

critical issue, and I think we can help provide resources in terms 

of technical assistance of how to utilize water. 

The research that is being done today for the most part is focused in this country on large farms, but the reality is that the 

vast majority of farms worldwide are very small farms. So it may 

not take a lot of technical assistance. It may be fairly rudimentary 

to provide drip irrigation systems that might be very inexpensive. 

We just need to figure out strategies to help these farmers be 

more productive, to help them to be able to access trade opportunities, and help them to be able to be self-sufficient, and when and 

if it becomes necessary, we need to be prepared to provide emergency assistance and maybe in a more efficient, more effective way 

as was outlined earlier today. 

Senator KOHL. Very good. 

RURAL COMMUNITY FORUMS

You have held several rural community forums across the country. I understand you may be holding more. What kinds of things 

have you been discovering? What kind of information have you 

been gathering? 
86 

Secretary VILSACK. Well, it somewhat depends on the area of the 

country, but I think that there is a real strong desire on the part 

of rural America to participate in helping reduce our dependence 

and our addiction to foreign oil. I think there is a belief that whether it is biomass or whether it is corn-based ethanol or whether it 

is new alternative feedstocks, there is a real desire for America to 

be producing its own energy. 

And there is concern, as you well know—and Senator Brownback, I am sure you know as well—about the existing infrastructure for the ethanol industry and the biofuel industry. So we are 

working with our credit friends, Farm Credit and others, to try to 

figure out strategies and ways in which we can make resources 

available or restructure the resources we have so that we maintain 

that infrastructure. 

Then the President has provided a directive to us to accelerate 

the implementation of the energy provisions of the farm bill. We intend to meet the deadline he has set for us. So very, very shortly 

you will see proposals relative to second-and third-generation feedstocks, resources for new biorefineries, resources to convert existing 

biorefineries, to use these new feedstocks, and assistance for producers to produce these new feedstocks. That is one thing that we 

are hearing. 

Then the dairy issue we have discussed is a serious issue, and 

we have tried to outline the fact that we have taken steps. Pork 

producers are feeling stress. Part of our challenge is that we have 

tools to respond to situations like this, but to a certain extent, because of decisions that are made to direct section 32 resources, 

sometimes our capacity to respond in as large a way as necessary 

is a bit compromised. So we are trying to figure out ways in which 

we can encourage, for example, institutional buyers to focus on purchasing pork to take some of the pressure off that industry, and we 

are obviously working hard on trying to reduce trade barriers. 

I think there is a genuine concern in rural communities. They 

are anxious to know that the Recovery and Reinvestment Act relates to them. When they hear a water treatment facility being 

funded in their town or they hear a health care facility being expanded or equipped because of resources or they hear that the river 

that has flooded every year is not going to flood or that they are 

going to receive some relief from that because of what USDA has 

done, they are appreciative. 

And then we have made an effort to make sure that they not 

only know the resources that are provided from USDA, but they 

have a sense of all the other resources that are being provided from 

other departments of Government. I think that is a reassuring 

message. 

Senator KOHL. Very good. 

Senator Brownback. 

Senator BROWNBACK. Thank you very much. 

THE NEW HOMESTEAD ACT

Mr. Secretary, a couple things. You started off talking about 

wealth creation on a regional approach which perked my ears up 

that we need to do that in rural areas, and we certainly do. We are 

losing a lot of population in rural areas. 
87 

May I suggest you or your staff take a look at a bill several of 

us put together and have for a series of years called the New 

Homestead Act? Senator Dorgan, previously Senator—well, several 

from the Midwest, myself have put this forward as a way to try to 

get more investment and growth taking place in rural areas. We 

worked at it a long time. We modeled it after what was done in 

this country in the 1970s to get the urban areas to go again. And 

we put in a series of tax incentives in particular that just applied 

to rural areas in counties that had lost population over the last 20 

years. So you are trying to target just those areas that have lost 

population. I think Iowa had half of its State, as half of mine, qualify in that. Then you have got a whole swath. We took things that 

had worked previously in the urban areas to get regeneration taking place that we think would work in the rural ones. I would hope 

you would take a look at that. We put a fair amount of time in it. 

I want to show you a bag, if I could. We did not fill it, but I am 

sure, if you have not seen one of these, you are going to see a 

bunch of these. 

Secretary VILSACK. I have one in my office. 

Senator BROWNBACK. Good. So you are well aware of this. I love 

these. I see them around the world. I love the American flag on it. 

I love the partnership on it. So that piece of it I like. 

CORN-SOY BLEND

The point I wanted to make is it is a corn-soy blend. Great. All 

for corn-soy. But this formulation has not been changed in 30 

years. That was when we developed the corn-soy blend for food aid, 

30 years ago, and we have not changed what we are shipping in 

30 years. 

Now, the reason I make that point is that they polled a series 

of Nobel laureates and said, if you were going to put money anywhere in the world to improve the status of humanity, what would 

you do? And the top one and third thing were both micronutrients 

that they said. Cheap, effective. If you took that corn-soy blend and 

you added proper levels of iodine, zinc, vitamin A, and iron into it 

for children at the right age, you would have dramatic impact. It 

is not heavy to do that, but it does require some reformulation of 

it to do. 

Tufts University is doing a study right now—maybe you know 

about this—on its reformulation. And I am looking at this and 

going, this is cheap for us to be able to do. We dramatically improve lives and we use that adjacent to what we are doing on AIDS 

and malaria in Africa particularly, and our outcomes get dramatically better. It is simple and it is cheap. So I would hope you could 

look at this Tufts study in this area just of micronutrients. 

Now, you have got to fund it all. That is the trick for everybody. 

One of the things we are looking at is to say, okay, if we are spending 65 percent right now on administration and transportation for 

our food aid, what if we could put a hard level that we cannot 

spend anymore than 45 percent for administration and transportation? That is pretty generous right there. You are going to spend 

nearly half your budget just to administer and get it there. And 

then use your delta difference to get the micronutrients in this and 
88 

to target it so you do not have new funds having to go into it, but 

you dramatically improve your outcomes with it. 

We are researching that. I would love to work with you on it. You 

have far more resources to do this than we would. I think the resources are there if we sharpen our pencil on those two areas and 

then look at what we can do in this field. 

I wish you godspeed there at Ag, Secretary. That is a great spot, 

and I am sure you will do a great job at it. 

Senator KOHL. Thank you, Senator Brownback. 

WIC FUNDING

Mr. Secretary, would you talk about WIC? Do you think we are 

adequately funded for this year? Are you worried about having to 

come back for more? What do you see for WIC? 

Secretary VILSACK. Senator, we have made our best estimates in 

terms of what we have proposed, and I believe we also have some 

contingency language in the WIC program. We believe 9.8 million 

participants is a very good, healthy estimate of what the program 

will be, and I believe we have provided resources and funding for 

that level. This is, obviously, a very important program and one 

that we are fully supportive of and one that is consistent with the 

President’s desire to assist in ending childhood hunger. So we are 

committed to it, as we are with the SNAP program and as we are 

with the Child Nutrition Reauthorization efforts that will be undertaken this year. 

Senator KOHL. Very good. 

RENEWABLE ENERGY PROGRAM DIRECTION

Would you amplify a little bit your vision of USDA’s role in terms 

of the administration’s renewable energy program in years to 

come? 

Secretary VILSACK. I would be happy to, and it really dovetails 

a little bit with what Senator Brownback was talking about earlier 

in terms of rural development and regional development. 

The administration, first and foremost, is committed to an expansion of the biofuels industry. The President established a working 

group recently directing myself, Secretary Chu and Administrator 

Jackson to figure out strategies for expanded marketing of biofuels. 

We are in the process of having staff meet to try to figure out ways 

in which that can be done. 

As I said earlier, first and foremost, we have to maintain the infrastructure that we have. That is a challenge with the current 

credit circumstances of some of those entities. 

Second, I think we have to continue to—and we will continue— 

invest in research that allows us to be more efficient with ethanol 

and soy diesel and biodiesel and biofuels that we are currently producing both in terms of the energy that is used and in terms of the 

natural resources that are required, specifically water. There is a 

lot of interesting, exciting research and activity being done to reduce the amount of energy and to reduce the natural resources in 

producing those fuels. 

The third thing is to continue to promote—and we will, as I indicated earlier—with the energy title of the farm bill, all aspects of 

the energy title of the farm bill identifying second- and third-gen-
89 

eration feedstocks. There are interesting efforts and demonstration 

projects underway using corn stover, the corn cob, the husks of 

corn. There are interesting opportunities potentially with grasses. 

There clearly is an effort in woody biomass. We are trying to link 

that effort up with opportunities with the Department of the Interior and Agriculture as we try to maintain our forests in an appropriate way and reduce the hazardous fuel that currently exists in 

our forests, to reduce the intensity of fires. All of that can create 

an opportunity for us, and there are some resources, you well 

know, to create demonstration projects in that area. We will aggressively pursue that. 

We are working hard, once the rules are out, to put resources to 

work creating new biorefineries. We have already at least announced one grant, a joint grant between ourselves and the Department of Energy, to accelerate research, but we are also providing 

resources to build new biorefineries. We are trying to identify biorefineries that want to convert their production process. We are 

able, because of the money that you all put in the farm bill, to be 

able to assist them in making that conversion. 

We are looking for farmers who are obviously interested in helping us produce the feedstocks of the future and provide resources 

and assistance for them to do so. 

We are also working with communities trying to identify communities that will want to convert to using woody biomass to produce 

some of their power. 

That is part of the strategy that wraps around the whole notion 

of renewable fuel and energy which we think is a growth opportunity for rural America. Whether it is wind or solar, hydro, geothermal, we think that there are enormous opportunities in rural 

communities if we are strategic and if we are smart about the 

transmission challenges that renewable energy presents. 

We are currently thinking about and working on how you would 

distribute biofuels, whether it is through the current system or 

through a pipeline system. I know that there are some Members 

of Congress who are interested in looking at the possibility of a 

pipeline that would make it easier to transport biofuels that are 

produced from, say, the Midwest to other parts of the country or 

from other parts of the country to the Midwest. 

We are working on strategies to make sure that once we produce 

the biofuel, that it can be adequately marketed. So many stations 

today do not have adequate pumping or tank infrastructure. So 

there are opportunities, I think, for us to respond. We are looking 

at ways in which we can use our rural development resources to 

enhance gas stations, convenience stores to be better equipped to 

handle ethanol. 

We are also continuing to, obviously, articulate the desire and 

hope that we look at the blend rate that is currently at E10. We 

are hopeful that it will be expanded from E10 to somewhere between E10 and E15. That, obviously, will expand opportunity and 

send a clear, strong message particularly to the market and to 

lenders that we are in this for the long haul. 

So it is a wide variety of those things, and we are, obviously, expecting our car industry to respond by producing cars that are 

more amenable to flexible fuels. 
90 

ADDITIONAL COMMITTEE QUESTIONS

Senator KOHL. Very good. 

Well, we thank you for being with us, Secretary Vilsack. I am 

most encouraged with you as a person in terms of your knowledge, 

your enterprise, your energy, your ambition, and I am convinced 

you are and will be a great Secretary of Agriculture. Thank you for 

being with us today. 

We will hold the record open for a week for any additional questions. 

[The following questions were not asked at the hearing, but were 

submitted to the Department for response subsequent to the hearing:] 

QUESTIONS SUBMITTED BY SENATOR HERB KOHL

BROADBAND

Question. Mr. Secretary, for some years this Committee has supported extending 

high speed broadband service to the most remote, unserved areas of rural America. 

Substantial funds have been made available in annual appropriations bills, and $2.5 

billion was provided to USDA for this purpose in the Recovery Act. 

Please describe the progress that has been made in expanding broadband access 

to unserved rural areas. 

How is USDA working with the Commerce Department to utilize funds provided 

in the Recovery Act? 

When do you expect to start spending Recovery Act funds? 

In addition to the Recovery Act funds and substantial carryover from fiscal year 

2008, you are requesting a large increase in the 2010 appropriation. Please explain 

why you think this increase is needed. 

Answer. The Rural Utilities Service has made substantial progress in providing 

assistance to unserved and underserved rural areas. Since 1995, we have required 

all new telecommunications capacity that we finance to be broadband capable. We 

have had great success with our Community Connect and Distance Learning and 

Telemedicine programs, providing more than $425 million in funding for these programs. Our broadband loan program, created by the 2002 Farm bill, has provided 

over $1.1 billion in loans to more than 90 broadband projects in rural communities 

spanning 42 States. 

The Recovery Act marks a major new chapter in this effort. Since its enactment, 

we have worked side by side with our partners at Commerce, the FCC and the 

White House to fulfill the President’s vision for promoting broadband access across 

the Nation. This was an unprecedented collaborative process between these two 

Cabinet level agencies. 

Since the Recovery Act was enacted in February, USDA and Commerce held six 

joint public meetings and published and Request for Information in the Federal Register to solicit input from the public. We determined early on that the two Departments need to join forces and make the process as seamless as possible. One application, one Notice of Funding Availability (NOFA), and one web portal 

(broadbandusa.gov) were developed. 

Our first joint NOFA is expected to be published in the Federal Register in July. 

This NOFA will be making $4 billion available for broadband infrastructure loans, 

grants, and loan grant combinations targeted to underserved and underserved 

areas. 

Immediately thereafter, USDA and Commerce will hold 10 joint Outreach and 

Training Workshops in 10 States on how to apply for the program. 

At the end of the application window, USDA and Commerce is expecting to receive applications seeking funding from the $4 billion made available under this 

first NOFA. We expect to begin making awards in November. 

With regard to the fiscal year 2010 budget, USDA is seeking the same deliverable 

broadband program level as fiscal year 2009. The increase in the appropriation request stems from an increase in the budget authority cost. 

CIVIL RIGHTS

Question. We are pleased, Mr. Vilsack, that you are aggressively addressing longstanding civil rights issues at the Department. Because the Pigford case remains 
91 

in litigation, we understand you cannot freely discuss it. However, please tell us 

what you can about progress toward resolving those claims. Has the Administration 

submitted to Congress a legislative proposal requesting the $1.25 billion to fund settlements? If not, when do you expect that proposal to be submitted? 

Answer. USDA has been working with the Department of Justice, which has the 

lead in negotiating the settlement for the Government. Once more details are 

known, legislation will be submitted to carry out the settlement. I have asked that 

additional information be provided for the record. 

[The information follows:] 

On August 28, 1997, a group of African American farmers filed a class-action lawsuit against USDA in Federal district court, alleging discrimination in USDA farm 

loan and farm programs (originally Pigford et al., v. Ann Veneman, now Pigford et 

al., v. Tom Vilsack). The court certified the class, and entered a Consent Decree on 

April 14, 1999. 

The certified class was described as all African American farmers who: (1) farmed, 

or attempted to farm, between January 1, 1981, and December 31, 1996; (2) applied 

to USDA during that time period for participation in a Federal farm credit or benefit program and who believed that they were discriminated against on the basis 

of race in USDA’s response to that application; and (3) filed a discrimination complaint on or before July 1, 1997, regarding USDA’s treatment of such farm credit 

or benefit application. USDA has been implementing the Consent Decree since 1999, 

and the last of the claims were recently routed for processing. 

In June of 2008, Congress enacted legislation, Section 14012 of the Food, Conservation and Energy Act of 2008 (Act), which affords individuals who did not file 

timely claims under the Consent Decree, judicial recourse in the U.S. District Court 

for the District of Columbia, for any Pigford claimant who has not previously obtained a determination on the merits of a Pigford claim. 

Consequently, as of September 18, 2009, 17 civil action complaints have been filed 

in the U.S. District Court for the District of Columbia, by 29,938 plaintiffs. The U.S. 

District Court Judge entered an order suspending the requirements about USDA 

providing loan data, while the Court considers the class certification issue. The parties have been negotiating a resolution of the cases since last year. President Obama 

proposed in his fiscal year 2010 budget $1.15 billion for the sole purpose of settling 

the cases. 

NATIONAL INSTITUTE OF FOOD AND AGRICULTURE (NIFA)

Question. What is the status of hiring a NIFA director? The budget request includes an increase of $23 million to help rural producers and citizens learn to use 

new technologies. Can you expand on what this will do? How many people will receive assistance with this? 

Answer. Dr. Roger N. Beachy, the founding president of the Donald Danforth 

Plant Science Center in St. Louis, MO, has been appointed the first director of the 

National Institute of Food and Agriculture (NIFA) by President Barack Obama. 

Beachy will join the agency on October 5, 2009. 

NIFA is requesting $23,000,000 to improve rural quality of life to support a competitive Smith-Lever 3(d) program focused on developing technology based system 

competencies for agricultural producers and food processors, and rural citizens. 

Mounting this program through Smith-Lever 3(d) will take advantage of the powerful existing infrastructure of both 1862 and 1890 land-grant institutions. This program will enhance the adoption and diffusion of broadband, as well as other information access technologies, and other new technologies (sensor systems, monitoring 

and tracking systems, nanotechnology, and decision systems). These information 

and other technologies can support rural entrepreneurship, sustain jobs in rural and 

isolated areas, and address a wide range of agricultural and food production and 

processing issues. 

A cornerstone of this program would be the establishment of an Extension Rural 

Technology Corps which would build on the national infrastructure of Cooperative 

Extension which serves every location in the country through county and regional 

offices supported by a Federal/State/local partnership, and through the nationwide 

Extension system. The Corps could work in collaboration to educate rural citizens 

to fully utilize broadband and other information technology access to support entrepreneurship, remote jobs, decision assistance, and community linkages. The Corps 

would complement the expansion of broadband to rural areas and support rapid, 

creative, and effective use of the technology. 

Second, the program would expedite the adoption and diffusion of new technologies to address rural and agricultural issues, to support the vitality of rural 

areas. For example, sensing, monitoring and tracking weather borne crop diseases 
92 

can both improve production efficiency and reduce environmental impacts by minimizing expensive pesticide purchases and application. New technologies, properly 

applied and interpreted can help rural communities cost effectively monitor environmental conditions, such as water quality. In addition, new technologies across a 

broad spectrum, including energy systems, provide opportunities for rural entrepreneurship. 

The Extension system serves citizens in every county in the United States. This 

effort, however, would focus on the needs of citizens in rural and isolated areas, 

helping at least 500,000 households and businesses improve utilization of new information technologies. 

MC GOVERN-DOLE INTERNATIONAL FOOD FOR EDUCATION PROGRAM

Question. Mr. Secretary, the McGovern-Dole program is an important tool for 

fighting world hunger. For many children in poor countries, the McGovern-Dole 

meal they get at school is the only one they’ll receive that day. This program has 

received around $100 million annually in discretionary funds. I am pleased to see 

a significant increase in your budget request. Can you discuss the impact such a 

large increase will have on this program? 

Answer. The 2010 budget request doubles the level of discretionary funding for 

the McGovern-Dole program. The increase will allow USDA to augment significantly 

the number of beneficiaries served as well as increase the benefits for those already 

participating in the program. The World Food Program estimates there are 75 million children who do not attend school and, for those who do attend, 60 million are 

hungry. The increase will help USDA to reduce these numbers, while at the same 

time support activities that encourage school enrollment and attendance, improve 

health and nutrition, and enhance future economic development of the country. 

Question. How many additional children will be served? 

Answer. It is estimated that the number of beneficiaries will increase from approximately 3 million in fiscal year 2009 to 4.5 million in fiscal year 2010. 

Question. Do you envision the program entering new countries with this increase? 

If so, which ones? 

Answer. It is possible that USDA could enter new countries in fiscal year 2010 

with this increase. However, it is difficult to say how many and which countries. 

That will depend upon the proposals that USDA receives in terms of country selection and the level of funding requested and approved for the proposed country programs. 

NIFA EDUCATION REQUEST

Question. The budget includes an increase of $41 million for Higher Education 

Programs, including teacher incentives, curriculum development, and other activities. Will USDA be working with the Department of Education in this endeavor? Are 

there overlapping activities within USDA and the Department of Education here? 

This request has a significant outcomes associated with it, with a wide variety of 

activities to be undertaken with this money. If you really want to meet these outcomes, is this request enough? 

Answer. Yes, opportunities exist for USDA and the Department of Education to 

coordinate resources on this initiative and we will pursue those opportunities. Specifically, staff within the Department of Education’s Fund for the Improvement of 

Postsecondary Education (FIPSE) competitive grants program have the expertise to 

assist USDA. FIPSE grants, like several of USDA’s Higher Education grants identified for this funding increase, support innovative teaching improvement projects 

that promote revitalizing rural American communities. These grant programs already effectively fund academic advancements in education, and support new ideas 

and practices to improve how students learn. However, at current funding levels, 

these grant programs primarily fund projects at individual academic institutions. 

Significant outcomes are expected with this additional funding increase. We envision additional funding will enable establishment of new, regional Centers of Excellence where partnerships between educators and employers establish best practices 

in curriculum content and delivery through a local academic collaborative. These regional collaborative models will reduce duplication of effort while increasing instructional efficiency. 

DAIRY

Question. Mr. Secretary and Mr. Glauber, the dairy sector is facing enormous 

challenges and this concerns me a great deal. Economic turmoil has diminished demand and prices paid to farmers have plummeted. We worked to strengthen the 

MILC safety net in the Farm bill, and you’ve taken steps by purchasing surpluses 
93 

and utilizing the Dairy Export Incentives Program. What trends do you see ahead 

for the dairy sector? 

Answer. Prices and farm income are expected to recover to more sustainable levels as demand increases with economic recovery over the next 2 years. The size of 

the dairy herd is projected to return to the long-term trend of decline that was interrupted from 2005 through 2008 by rapid worldwide economic growth that brought 

increased dairy product demand. 

Question. When might we begin to see positive outcomes from the steps that have 

already been taken? 

Answer. Milk prices have begun to increase. [Clerk’s note: The following response 

is based on information available after the date of the hearing.] The all-milk price 

hit the lowest level in 6 years during June and July 2009. Product shipments 

through the Dairy Export Incentive Program and actions taken through the Dairy 

Product Price Support Program brought price increases in August with the all-milk 

price increasing $0.50 per hundredweight. This increase will be reflected in the Milk 

Income Loss Contract Program checks that producers receive during September for 

their August milk production. Further increases in the milk price are projected 

through next year. 

RESOURCE CONSERVATION AND DEVELOPMENT COUNCILS (RC&DS)

Question. Mr. Secretary, for the past several years, the budget request for RC&Ds 

has been zero. This subcommittee continues to fund this program each year. Can 

you explain what the practical effect would be of not funding RC&Ds? 

Answer. As nonprofit organizations, RC&D councils will still exist in the short 

term. However, while some councils may have the financial and staff capacity to 

continue operating, we expect that most councils would cease to function effectively 

without the support of professional NRCS coordinators. As a result, the strategic 

planning and delivery of many conservation, renewable energy, and economic development projects in local communities would halt. 

Question. There are approximately 451 staff years associated with RC&Ds. What 

will happen to these staff should this subcommittee not provide funding? Will anyone lose their job? 

Answer. RC&D staffing adjustments are being considered as part of NRCS’ 

human capital analysis and plan. Since NRCS is facing significant retirements in 

the future, all appropriate staffing incentives and adjustments are being considered. 

However, specific plans have not been finalized. Implementation of any plan for fiscal year 2010 would not be initiated until Congressional action on the President’s 

Budget is known and necessary decisions have been made. NRCS intends to retain 

as many RC&D staff as the overall NRCS budget will support. Skills learned as a 

RC&D coordinator serve employees well in many other NRCS positions. The ability 

to foster partnerships, collaborate, and plan projects is essential to all NRCS field 

and State level technical positions. These employees can be placed in other NRCS 

field and State office positions such as district conservationist and other natural resource positions. 

Question. Would the current functions of RC&Ds be absorbed within NRCS? If so, 

how? 

Answer. As nonprofit organizations, RC&D Councils will still exist. The current 

functions of the Federal RC&D Program would not be provided to assist the Councils. Those functions would not be absorbed within NRCS. While NRCS would continue to deliver conservation projects on individual agricultural operations through 

Conservation Technical Assistance and the Farm bill conservation programs, NRCS 

would not absorb the valuable strategic natural resource conservation and economic 

development planning and project delivery function of the RC&D Program. Likewise, NRCS’s remaining conservation planning and delivery programs would not 

support the leveraging of significant State, local, and private funding as provided 

by the RC&D Program. In fiscal year 2008 alone, the RC&D councils leveraged a 

total of $189 million from non-Federal sources to support 4,500 projects around the 

country. 

WIC

Question. I am pleased to see in your budget a more robust request for WIC. As 

you know, this subcommittee has had to provide significant increases for WIC, often 

times at the expense of other important programs. Do you expect to release any contingency funds from fiscal year 2009? Taking into consideration the 2009 stimulus 

and the fiscal year 2010 request, what will the total amount available for WIC contingency be in fiscal year 2010? Do you anticipate having to use any of that contingency to maintain participation in fiscal year 2010? Taking into account the current 
94 

state of the economy, do you see food prices and participation increasing over the 

next few months? 

[Clerks Note: The following response is based on information available after the 

date of the hearing.] 

Answer. The total available in the WIC contingency reserve in fiscal year 2009 

is $525 million, including $400 million provided in the Recovery Act. Of the total 

available, $38 million will be used in fiscal year 2009, leaving $487 million to be 

carried over into fiscal year 2010. Together with the $225 million in the budget request, the total contingency reserve available for fiscal year 2010 is $712 million. 

Based on current estimates for program participation and food costs, the funding 

levels proposed by the President’s 2010 budget appear sufficient to ensure that all 

eligible individuals seeking benefits can receive them in fiscal year 2010 without 

using any of the $486.8 million in available contingency funds. 

WIC food package cost estimates are based on monthly food inflation forecasts 

provided to FNS by the Economic Research Service (ERS). Food prices over the next 

few months may begin to increase slightly. FNS estimates that the WIC food package cost will increase 3.1 percent during fiscal year 2010 from $42.82 to $44.18. 

FNS has typically based its participation projections on trends over the past 7 

years. However, given the current state of the economy, FNS believes that participation is likely to grow at a stronger rate through fiscal year 2010, closer to the rate 

realized in fiscal year 2008 than to the 7-year average. FNS projects that average 

monthly participation will be 5.6 percent higher in fiscal year 2010 than in fiscal 

year 2009 from 9.1 million to 9.6 million participants. 

RENEWABLE ENERGY

Question. Mr. Secretary, we are aware that expansion of renewable energy production and energy efficiency improvements are high priorities of you and this Administration. Those priorities are well represented in the increases you are requesting in this budget. 

Over the last several years USDA has provided substantial support for the expansion of corn-based ethanol facilities. With the current recession and reduced oil 

prices, what are the short-term prospects for these facilities? 

Answer. As the economy begins to stabilize and emerge from its deep recession, 

our hope is that demand for renewable fuels will continue to grow along with other 

sectors of the economy. Our reports show that those corn-based facilities that weathered the financial crisis are beginning to show profitability. 

Question. Do you think additional support will be needed from the Department 

to sustain these projects? 

Answer. USDA is undertaking an unprecedented effort to provide relief to businesses in struggling agricultural industries through the American Recovery and Reinvestment Act funding received under the Business and Industry Loan Guarantee 

Program. This program has been put to work to partner with lenders in helping to 

assist processors and other businesses connected with the agricultural sector meet 

their current financial needs for capital. 

Question. Is the demand for the Biorefinery Assistance Program and the Rural 

Energy for America Program as strong as you had anticipated? 

Answer. The future of the biofuels industry partially lies in the commercialization 

of second and third generation feedstocks. The Section 9003 Biorefinery Assistance 

Program is a critically important investment in that evolution. 

Numerous potential applicants for the Biorefinery Assistance Program have expressed their inability to obtain a lending partner in order to apply for a loan guarantee to assist with the construction of a viable commercial biorefinery under the 

Section 9003 Program. Based on discussions with the lending community and the 

current economic climate, they are reluctant to consider this loan guarantee program without the government taking more of the risk than currently is being taken 

under the program. We will not know for certain the true level of demand for the 

Section 9003 Program until regulations are promulgated and a new solicitation of 

applications is conducted. That is expected to occur toward the end of fiscal year 

2010. 

The 2008 Farm bill authorized the Rural Energy for America Program in Section 

9007 which expands and renames the program formerly called the Section 9006: Renewable Energy Systems and Energy Efficiency Improvements Program. Since the 

enactment of the first-ever Energy Title in a Farm bill in 2002, this program has 

provided grants and loan guarantees to rural residents, agricultural producers, and 

rural businesses for more than 1,800 energy efficiency and renewable energy 

projects ranging from biofuels to wind, solar, geothermal, methane gas recovery, and 

other biomass. 
95 

Question. The President’s budget requests substantial increases of discretionary 

funding over and above the mandatory funds in the Farm bill for these programs. 

Are these increases still needed? 

Answer. As noted in the answer to the prior question, we will not know for certain 

the true level of demand for the Section 9003 Program until the end of fiscal year 

2010 when we begin to accept applications under new regulations and a new notice 

of solicitation. 

Preliminary results show that the Rural Energy for America Program received 

1,887 applications requesting in excess of $120 million. The demand for this program far exceeded the funding for fiscal year 2009. We anticipate the demand for 

this program to continue to grow significantly in fiscal year 2010. 

MICRO-ENTERPRISE PROGRAM

Question. Mr. Secretary, this Committee is very interested in implementation of 

the new micro-enterprise program authorized in the 2008 Farm bill. This program 

will provide loans and technical assistance to support job creation and income generation through entrepreneurial development in rural areas. The Farm bill makes 

available mandatory funding for this program from 2009 through 2012. 

Please describe the current status of this new program, and your vision of its potential to increase economic wellbeing in rural areas. 

Answer. We expect the proposed rule to be transmitted to the Office of Management and Budget by September 30, 2009, for review and the agency is seeking an 

expedited review. We anticipate publishing a final rule by the end of June 2010, and 

will then be able to articulate our vision of the program’s potential to increase economic wellbeing in rural areas. 

Question. This budget request includes an increase of $22 million over the $4 million of mandatory money provided by the Farm bill. Is this large increase merited 

at this early stage of development of the program? 

Answer. The Agency seeks to utilize the funding to help jump start rural economies through self employment. We believe there will be considerable demand for the 

increase in funding. The program includes a lending component as well as a training and technical assistance component which will contribute to the long term success of the affected businesses. 

ANIMAL IDENTIFICATION

Question. I understand that in the rural community forums there was a lot of talk 

about the National Animal ID Program. What did you learn from those listening 

sessions? Do you believe this should be a mandatory or voluntary program? If it’s 

made mandatory, what would be the cost to producers? 

Answer. USDA hosted public listening sessions so that I could hear from producers and stakeholders throughout the country—not only their concerns but also 

potential or feasible solutions to those concerns. The transcripts of the listening sessions are available on APHIS’ webpage: http://animalid.aphis.usda.gov/nais/feedback.shtml. USDA also invited the public to submit written comments via the 

website, which we received thousands of before the comment period closed on August 3, 2009. While the analysis continues, several clear themes have emerged from 

the call for feedback. 

One such theme is confidentiality of the business information. Some believe that 

business information must remain confidential to allow for fair competition in the 

marketplace. Another theme is liability, and the potential for lawsuits, should something enter the food supply and cause harm. We also heard concerns about cost. 

Some believe the costs of identifying and tracing animals are prohibitive. Finally, 

privacy was another significant theme. Some see animal identification as an unwelcome intrusion by the Federal Government. USDA is continuing to review the transcripts from each session as well as the written comments that were submitted by 

the public. 

Given the public’s concerns, USDA must find a way to achieve the original and 

true purpose of the National Animal Identification System—animal traceability. The 

goal is to enhance traceability efforts in ways that respond to these concerns, recognizing and seeking to overcome the shortcomings of our efforts to implement NAIS 

in the last 5 years. The feedback we received from the public, along with the lessons 

learned over the past several years, will assist in making informed decisions about 

the future direction of animal identification and traceability in the United States. 

USDA has not specifically estimated the costs to producers of a mandatory system, as the previous Administration had not pursued such a system and the Administration is still determining a comprehensive approach to traceability. 
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WATERSHED FLOOD PREVENTION OPERATIONS PROGRAM STATUS

Question. Mr. Secretary, this subcommittee provided $290 million for the Watershed Flood Prevention Operations Program through the American Recovery and Reinvestment Act. 

Can you please provide an update on the status of these funds? 

Answer. Of the $290 million appropriated, NRCS has allocated over $256 million—$133 million for 80 approved Watershed and Flood Prevention Projects, $118 

million for 270 approved Flood Plain Easements and $5 million for agency-wide support. As of September 18, 2009, over $103 million has been obligated. 

[The information follows:] 

State Total allocations Total obligations 

Watershed and Flood Prevention Operations 

Alabama .................................................................................................................................. $430,000 $18,411 

Arkansas .................................................................................................................................. 134,000 69,666 

California ................................................................................................................................. 19,275,000 2,293,104 

Colorado .................................................................................................................................. 3,841,900 1,350,835 

Idaho ....................................................................................................................................... 430,000 9,717 

Indiana .................................................................................................................................... 3,300,000 28,038 

Iowa ......................................................................................................................................... 2,231,750 732,079 

Kansas ..................................................................................................................................... 1,661,000 50,873 

Kentucky .................................................................................................................................. 4,817,880 217,840 

Louisiana ................................................................................................................................. 4,470,000 1,044,304 

Minnesota ................................................................................................................................ 544,000 436,552 

Mississippi .............................................................................................................................. 7,630,000 2,268,643 

Missouri ................................................................................................................................... 4,900,000 945,818 

Montana .................................................................................................................................. 822,700 271,458 

Nebraska ................................................................................................................................. 4,209,000 1,524,840 

New Mexico .............................................................................................................................. 1,440,000 25,555 

New York ................................................................................................................................. 1,000,000 147,438 

North Carolina ......................................................................................................................... 5,280,858 134,749 

Oklahoma ................................................................................................................................ 3,619,000 1,826,996 

Pacific Islands ........................................................................................................................ 4,150,000 80,369 

Pennsylvania ........................................................................................................................... 11,900,000 10,379,210 

South Carolina ........................................................................................................................ 1,040,000 19,912 

Tennessee ................................................................................................................................ 12,400,000 1,111,862 

Texas ....................................................................................................................................... 21,786,111 8,105,239 

Virginia .................................................................................................................................... 973,000 284,144 

Washington .............................................................................................................................. 625,000 533,940 

West Virginia ........................................................................................................................... 10,085,000 150,958 

Agency wide ............................................................................................................................ 3,684,200 1,117,776 

Total ........................................................................................................................... 136,680,399 35,180,326 

Flood Plain Easements 

Alabama .................................................................................................................................. 2,788,488 1,640,774 

Alaska ...................................................................................................................................... 740,112 151,033 

Arkansas .................................................................................................................................. 1,890,000 1,356,112 

California ................................................................................................................................. 5,366,400 4,335,977 

Colorado .................................................................................................................................. 111,293 10,834 

Connecticut ............................................................................................................................. 31,000 31,000 

Georgia .................................................................................................................................... 3,100,218 31,880 

Idaho ....................................................................................................................................... 19,800 19,739 

Illinois ...................................................................................................................................... 3,325,800 2,692,893 

Indiana .................................................................................................................................... 7,898,693 6,671,586 

Iowa ......................................................................................................................................... 20,855,846 12,586,216 

Kansas ..................................................................................................................................... 2,007,432 1,680,570 

Kentucky .................................................................................................................................. 3,245,582 2,548,135 

Louisiana ................................................................................................................................. 2,221,769 982,070 

Maine ....................................................................................................................................... 88,294 85,046 

Maryland .................................................................................................................................. 19,963 19,862 

Michigan .................................................................................................................................. 497,100 435,407 

Minnesota ................................................................................................................................ 1,524,776 1,028,453 

Mississippi .............................................................................................................................. 2,125,116 1,620,622 
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State Total allocations Total obligations 

Missouri ................................................................................................................................... 4,171,582 1,189,791 

Montana .................................................................................................................................. 10,468 10,468 

Nebraska ................................................................................................................................. 350,820 289,646 

New Hampshire ....................................................................................................................... 407,822 140,025 

New Jersey ............................................................................................................................... 745,164 578,882 

New York ................................................................................................................................. 782,466 56,078 

North Carolina ......................................................................................................................... 443,400 322,562 

North Dakota ........................................................................................................................... 10,210,554 3,804,286 

Ohio ......................................................................................................................................... 9,624,170 452,705 

Oklahoma ................................................................................................................................ 2,911,620 35,146 

Oregon ..................................................................................................................................... 2,275,770 1,182,059 

Pennsylvania ........................................................................................................................... 243,383 103,657 

Rhode Island ........................................................................................................................... 757,200 44,182 

South Carolina ........................................................................................................................ 87,700 87,643 

South Dakota ........................................................................................................................... 1,843,327 1,557,318 

Tennessee ................................................................................................................................ 1,589,154 182,227 

Texas ....................................................................................................................................... 5,516 5,516 

Virginia .................................................................................................................................... 35,754 36,344 

Washington .............................................................................................................................. 934,332 461,820 

West Virginia ........................................................................................................................... 749,426 448,497 

Wisconsin ................................................................................................................................ 22,057,287 18,619,779 

Agency wide ............................................................................................................................ 1,583,726 550,048 

Total ........................................................................................................................... 119,678,323 68,086,889 

FOOD SAFETY ASSESSMENTS

Question. The budget proposes an increase of $4 million for additional food safety 

assessments. How is a ‘‘food safety assessment’’ different from the regular inspections done by FSIS on a daily basis? How many food safety assessments does USDA 

currently perform, and how many additional assessments will be completed with 

this money? How will you determine which establishments will receive these additional assessments? 

Answer. A Food Safety Assessment (FSA) is a comprehensive look at the design 

and implementation of an establishment’s food safety system. FSAs cover the 

HACCP plan and supporting documentation, sanitation standard operating procedures (SSOPs), prerequisite programs, microbiological testing procedures, sanitation 

performance standards (SPS), establishment documentation, and other information 

that relates to the establishment’s products and processes. These assessments are 

in addition to the regular inspection verification activities performed by inspection 

program personnel daily at operating establishments. FSAs are performed by specially trained Enforcement Investigation and Analysis Officers (EIAOs). According 

to the USDA Office of Inspector General’s 2007 audit report, FSAs yield the Department’s best evidence about the design and implementation of an establishment’s 

food safety system. 

There are two types of FSAs, routine and for cause. The Department has committed to complete at least one routine FSA in each of the 5,400 establishments subject to the HACCP regulation every 4 years. In addition, the Department conducts 

for cause FSAs in establishments that have a higher probability of causing human 

illness. These are determined by assessing whether the establishments have produced product that tested positive for pathogens known to cause human illness, are 

found not to be in compliance with specific Federal regulations, or are performing 

worse than their peers with respect to FSIS verification activities. FSIS initiates approximately 300–400 for cause FSAs every year to address enforcement activities resulting from findings of E. coli O157:H7, Salmonella, Listeria monocytogenes (Lm) 

sampling and product recalls. 

The complexity of an establishment’s food safety system and the need for urgent 

reporting may result in more than one EIAO being involved in an individual food 

safety assessment. In the future, once the Public Health Information System is fully 

implemented, establishments meeting the criteria for a cause FSA will be more 

quickly identified through an automated process. 

In fiscal year 2008, the most recent year for which complete data is available, approximately 1,352 FSAs were conducted, both routine and for cause. The FSAs, primarily those conducted for cause resulted in 28 suspensions of operations and 135 
98 

notices of intended enforcement action. With the Department committed to conducting a routine FSA in each establishment every 4 years, the annual number of 

total number of FSAs, including routine and for cause, will increase to approximately 2,000. The $4 million budget increase includes hiring 20 additional EIAO full 

time staff and the laboratory costs associated with these additional FSAs. 

FOOD SAFETY INFRASTRUCTURE

Question. Mr. Secretary, in your statement, you mention the proposed FSIS in- crease of $23 million to improve food safety ‘‘Public Health Infrastructure’’, noting 

that it will strengthen FSIS’ ability to target inspections and investigate outbreaks. 

Those goals are impressive, but what exactly will this funding be used for? 

Answer. The Public Health Information System (PHIS) will protect public health 

through food safety and food defense inspection of the production and distribution 

of domestic and imported meat, poultry and processed egg products; ongoing and 

real time assessment, analysis and surveillance of public health data; and implementation of incident command procedures to address outbreaks of foodborne illness 

or contamination of food products. Specifically, the $23 million increase to the public health infrastructure is divided 

into two categories as described below. First, $13.5 million will be used for the scheduling of food safety and food defense 

inspection verification and sampling in 5,400 Federal domestic establishments, 134 

ports of entry and 1,900 State-inspected facilities; nationwide reporting of inspection 

verification and sampling results; integration of inspection and sampling data as 

well as other public health data into a data warehouse for real time assessment and 

analysis; and operation of an emergency response systems (particularly, the FSIS 

Incident Management System, Consumer Complaint Monitoring System and Recall 

Management System) on a 24/7 operational basis with full failsafe/redundancy capability at the USDA Data Centers. Second, the remaining $9.5 million will provide for systems, technical and telecommunication implementation and support for 9,500 FSIS and 1,400 State employees and enactment of Cyber Security controls to meet mandated authentication procedures and security policies, encrypt data and systems, perform vulnerability assessments and remediation to block and prevent evolving national and international 

threats and intrusions, and maintain system certification and accreditation necessary for the enablement and function of public health inspection and emergency 

response systems. 

RESEARCH

Question. Mr. Secretary, although you have stated several times that a top goal 

of the Administration is to pursue research regarding renewable fuels, the overall 

research accounts actually receive a net decrease in this budget. Although there are 

requested increases in the research accounts regarding renewable fuels, are you concerned that overall this is coming at a cost to more traditional agricultural research, 

important for increasing yields and expanding agricultural production? 

Answer. The Administration is committed to developing homegrown energy to end 

our dependence on foreign oil and revitalizing rural America. Therefore the President’s 2010 Budget continues to aggressively provide the resources needed to help 

bring greater energy independence to America and includes $88.63 million for bioenergy/renewable energy research and development. This is an increase of $9.68 

million over the Department’s 2009 budget and also eliminates $8.09 million in bioenergy earmarks. 

Much of the research related to bioenergy, such as functional genomics, resource 

management, productivity, and sustainability issues also address problems faced by 

traditional agriculture and will directly and indirectly promote the goals of increasing yields and expanding agricultural production. 

ANIMAL ANTIBIOTICS

Question. Some experts estimate that as much as 70 percent of all antibiotics sold 

in this country are used in food animals for purposes other than treating diseases 

and that this contributes to the rise in antibiotic-resistant bacteria. 

What research has USDA undertaken or funded to evaluate this threat? What 

work is being done to support development of alternatives for producers in the event 

that sub-therapeutic use of antibiotics is restricted in animal agriculture? 

Answer. Collaboration in animal health and food safety epidemiology (CAHFSE) 

is a joint effort among three agencies of the U.S. Department of Agriculture: the 

Animal and Plant Health Inspection Service (APHIS), the Agricultural Research 

Service (ARS), and the Food Safety and Inspection Service (FSIS). The mission of 
99 

this important surveillance effort is (1) to enhance overall understanding of bacteria 

that pose a food-safety risk by monitoring these bacteria on-farm and in-plant over 

time, and (2) to provide a means to routinely monitor critical diseases in food-animal 

production. A particular emphasis of CAHFSE is to address issues related to bacteria that are resistant to antibiotics. 

In March 2009, ARS contributed to the development of the Public Health Action 

Plan to Combat Antimicrobial Resistance, developed jointly by the Food and Drug 

Administration (FDA), Centers for Disease Control and Prevention (CDC), and National Institutes of Health. ARS, in collaboration with the FDA Center for Veterinary Medicine and the (CDC), is an integral member of the National Antimicrobial 

Resistance Monitoring System (NARMS). This system was implemented in 1996 

with a goal of monitoring trends in antimicrobial resistance in humans, animals, 

and retail meats. ARS is responsible for the animal sampling arm of NARMS and 

collects samples from slaughter plants, diagnostic laboratories, and healthy animals. 

As part of this effort, ARS is also conducting research to develop more sensitive detection methods to identify resistance-associated genes. NARMS has provided preliminary data on antimicrobial use, although this information is not yet linked to 

data on resistance. ARS has also conducted some pilot studies to monitor resistance 

in potentially emerging pathogens, such as methicilin-resistant staphylococcus 

aureus (MRSA), enterococci, and C. difficile. I will provide additional information for 

the record. 

[The information follows:] 

ARS is evaluating processing technologies that minimize foodborne pathogen contamination and determining what effect contamination levels have on the development of antimicrobial resistant pathogens. ARS also models the gene flow of certain 

antibiotic resistance factors and is developing strategies to extend the useful life of 

antibiotics in both animal and human medicine. 

ARS is currently using metagenomic (and also cultural) approaches to evaluate 

the effects of feeding subtherapeutic (growth promoting) and therapeutic antibiotics 

on swine intestinal microbiota. The goal of this effort is to identify changes in microbial composition associated with performance enhancement, and to define how 

growth promotants work to support the identification of alternatives with similar 

growth-promoting effects. Specifically, researchers are looking for changes in the 

gene content of swine exposed to one or more antibiotics. Also underway are plans 

to conduct field trials to test whether or not growth promoting antibiotics (such as 

carbadox) still work in swine and to investigate the utility of metagenomics for detecting changes in intestinal microbiota caused by marketed probiotics. 

ARS develops and evaluates non-traditional products or alternatives to antibiotics 

(e.g., probiotics, other natural products) and assesses what effect they may have in 

decreasing resistance. ARS is evaluating the role of antibiotic resistance in creating 

enhanced virulence or pathogenicity in bacteria (Salmonella in cattle). Researchers 

are also developing microarrays for the detection of antimicrobial resistance genes 

in bacteria and as a method to track the different genes responsible for virulence 

in bacteria. 

DAIRY PRICE SUPPORT PROGRAM

Question. Economic turmoil and plummeting prices have hit the dairy sector very 

hard. This administration has taken several welcome steps in an effort to mitigate 

the impact, but the strain on American dairy farmers is enormous. One further administrative step which I’d ask you to review involves the Dairy Product Price Support Program (DPPSP). 

In the past, USDA has purchased pasteurized processed cheese product, and paid 

a premium for it because it comes in consumer-ready packages. Cheese manufacturers in my area of the country typically sold pasteurized processed cheese as the first 

line of defense against rapidly falling milk prices. Unfortunately, that option is no 

longer available. 

What flexibility does the Department have to adjust the directive issued by the 

previous administration which eliminated pasteurized processed cheese purchases 

under the dairy support program? 

Answer. The Department has no flexibility to adjust the directive because the 

elimination of pasteurized process cheese was based on changes to the milk price 

support program in the Food, Conservation, and Energy Act of 2008 (2008 Farm 

bill). The Secretary is now directed to specifically purchase cheddar cheese under 

this program, rather than previous legislation directing the Secretary to purchase 

cheese. 
100 

ANIMAL IMPROVEMENT LABORATORY

Question. The Animal Improvement Program Laboratory (AIPL) in Beltsville, MD, 

conducts research to discover, test, and implement improved genetic evaluation 

techniques for economically important traits in dairy cattle. Due in part to their 

work, the United States is a world leader in dairy genetics and last year exported 

more than $105 million in bovine genetic material. Please describe current Federal 

support for bovine genetic and genomic work at AIPL and elaborate on steps being 

taken to ensure that the United States maintains its leadership role in dairy genetics. 

Answer. Genetic evaluation techniques for economically important traits have undergone a revolution in the past 2 years and the Animal Improvement Program Laboratory (AIPL) has led the way with increasing involvement of the Bovine Functional Genomics Laboratory (BFGL), a sister Agricultural Research Service (ARS) 

laboratory in Beltsville, MD. I have asked ARS to provide a progress report for the 

record. 

[The information follows:] 

USDA–ARS and its collaborators have developed a process to incorporate genomic 

information into the traditional genetic merit information based upon trait measurement (i.e. lbs. of milk, fertility, health) which dramatically improves the genetic 

merit evaluation. This current genetic evaluation scheme depends critically on incorporation of genomic data to predict genetic merit in dairy bulls. The effectiveness 

of these new techniques, and thus the rate of adoption of this technology in the U.S. 

dairy industry, has been astounding. In January of this year, less than 1 year from 

the delivery of the first preliminary research results using this technology, USDA– 

ARS scientists have incorporated this completely new information derived from 

DNA testing into the official national dairy cattle genetic evaluation. This technology transfer success was the result of a highly collaborative effort led by USDA– 

ARS scientists with collaboration among academic groups, artificial insemination organizations, and breed associations. Financial support was provided through competitive grants, collaborative agreements, and USDA base funds. To date, over 

35,000 animals have been genotyped, and that number continues to grow rapidly. 

Collection and use of performance data, improved record keeping and enhanced capability to associate performance with genomic markers continue to be cornerstones 

of the USDA–ARS efforts. 

The aggressive adoption of this technology in the U.S. dairy industry has outpaced 

implementation around the world, and as a result the ability to predict genetic 

merit in the U.S. dairy industry is more accurate than in any other country. A corresponding increase in the genetic level of U.S. dairy germplasm is a direct result 

of this technology adoption. The cost of progeny testing to determine a bull’s value 

could be as high as $50,000 per bull, whereas the genomic evaluation gives comparable accuracy at a cost of approximately $300 per bull. Using this DNA information, we are now able to generate genetic predictions for males much earlier in life 

with high accuracy and a dramatically lower cost. This technology is expected to increase the rate of genetic improvement by at least 50 percent. Some estimates suggest a doubling of the genetic gain to be more realistic. Because of this dramatic 

increase and the implementation lead gained by this rapid deployment in the 

United States, export opportunities for U.S. dairy germplasm are expected to increase substantially over time. 

Work to expand this technology is continuing in AIPL and BFGL. Scientists there 

are leading efforts to develop even more sophisticated DNA tools that will enable 

this technology to be implemented in beef cattle populations. In addition, these tools 

are being developed to help serve the needs of the developing world by incorporating 

information specific to cattle in tropical and sub-Saharan environments. 

To maintain its lead in dairy genetics and extend these tremendous results into 

other cattle populations, close collaboration with academic groups, artificial insemination organizations, and breed associations will continue. Innovation continues to 

be spurred by the exciting discoveries of implementing genome enhanced genetic improvement. Growth in the areas of bioinformatics, quantitative genetics and computational biology are needed to maintain and extend this lead. 

ARS funding support through AIPL is estimated at $2,893,200 and support 

through BFGL is estimated at $2,294,100. 
101 

QUESTIONS SUBMITTED BY SENATOR TOM HARKIN

ADVANCED BIOFUELS

Question. As you know, Secretary Vilsack, the 2008 Farm bill placed a heavy emphasis on providing support for advanced biofuels, including support for biomass 

feedstock development, support for harvesting transport and storage, and support 

for both pilot plant and commercial scale biorefineries for advanced biofuels. However, since the Farm bill was passed, credit markets have tightened significantly, 

so that even with assistance provided by the Farm bill programs, I am hearing that 

advanced biorefinery developers are having major difficulties is securing financing 

for start-up plants. This, in turn, is leading to the real possibility that the biofuels 

industry may not be ready to meet the requirements of our national renewable fuels 

standards (RFS) for advanced biofuels. 

Do you have a recommendation for how USDA might assist with this problem? 

Answer. Numerous potential applicants for the Biorefinery Assistance Program 

have expressed their inability to obtain a lending partner in order to apply for a 

loan guarantee to assist with the construction of a viable commercial biorefinery 

under the Section 9003 Program. Based on discussions with the lending community 

and the current economic climate, they are reluctant to consider this loan guarantee 

program without the government taking more of the risk than currently is being 

taken under the program. We will not know for certain the true level of demand 

for the Section 9003 Program until regulations are promulgated and a new solicitation of applications is conducted. That is expected to occur toward the end of fiscal 

year 2010. 

Question. Is more funding for the biorefinery support program advisable or essential for that? 

Answer. Mandatory funding received under the 2008 Farm bill is limited to loan 

guarantees. The 2010 Budget also requests funding to support loan guarantees. 

LOCAL FOODS—BUSINESS AND INDUSTRY LOAN AND GRANT PROGRAM

Question. The recently passed fiscal year 2009 Omnibus appropriations bill and 

American Recovery and Reinvestment Act provided significant funding for the Business and Industry loan program at USDA. The 2008 Farm bill modified the Business and Industry Program to allow local and regional food enterprises to be eligible 

for assistance under this program and requires that 5 percent of the annual funding 

under this program be reserved for these enterprises. 

Can you tell me what the department is doing in terms of outreach to encourage 

local and regional food enterprises to participate in this program? 

Answer. The department has a Know Your Farmer, Know Your Food Initiative 

and will be establishing a website where this program will be featured among all 

of the department’s resources to assist this effort. 

ACRE PROGRAM IMPLEMENTATION AND TRAINING

Question. Secretary Vilsack, the 2008 Farm bill includes a new counter-cyclical 

option called the Average Crop Revenue Election (ACRE) that uses average Statelevel crop revenue to establish a threshold for coverage. Farmers will have to actively elect to participate in this new program and agree to forgo a portion of their 

direct payments and to accept lower loan rates. I appreciate that you extended the 

time for farm program signup to give producers additional time to weigh the benefits of the program options. I am concerned, however, that local county FSA personnel may not have adequate training to help producers consider their program options. 

What training has the Farm Service Agency provided on the ACRE program and 

what plans are in place for additional training over the next few months? 

Answer. The Farm Service Agency has distributed fact sheets and extensive background information to the field staff and has conducted training meetings and 

webinars along with other efforts to ensure staff is adequately trained. However, we 

agree with you that further efforts to improve our employees’ and producers’ understanding of ACRE would be beneficial. The agency has set up a special website for 

DCP/ACRE which includes extensive detailed information, and a new program payment calculator to help producers evaluate their options. Plans call for additional 

State and county data files to be made available to further assist our employees and 

producers. Further, we are considering launching additional efforts to educate producers as well. 

Question. Would you consider targeting training in those States where producers 

are expected to be more interested in the ACRE program? 
102 

Answer. We will attempt to ensure that FSA staff in all States are adequately 

trained and equipped. However, States with higher numbers of eligible producers 

will likely receive priority for our special educational meetings. 

Question. Do you anticipate any computer-related problems as producers enroll in 

ACRE? 

Answer. While the FSA computer system remains a concern, we believe that the 

agency will be able to manage the signup process adequately with the current system. 

USDA AND DOE COLLABORATION

Question. The Department of Energy provides significant support for the development of biofuels, as well as USDA. Both agencies are supposed to work together in 

this arena. However, I believe that USDA is has a much better track record for supporting commercialization efforts, and that suggests that USDA and DOE should be 

collaborating on bioenergy program planning and execution. 

What is your perception regarding USDA and DOE collaboration in the area of 

bioenergy? Do you think it is adequate or optimal? 

Answer. USDA is satisfied with the level of collaboration with DOE in the area 

of Bioenergy, including the Biomass Research and Development Board. DOE presently provides USDA technical expertise in the review of Section 9003 Biorefinery 

Assistance and Section 9007 Rural Energy for America Programs (REAP) applications. 

Question. Do you have suggestions for improvements? 

Answer. One way to augment both programs would be to increase partnerships, 

in the combined issue of grants and loan guarantees to second and third generation 

biorefineries. This would allow both departments to leverage commercialization efforts of second generation biofuels. 

Question. And do your recommendations have budget implications? 

Answer. In the May 5, 2009, President’s Directive on Biofuels and Rural Economic 

Development, the President created a Biofuels Interagency Working Group cochaired by Secretaries of Agriculture and Energy and Administrator of EPA to develop the Nation’s first comprehensive biofuel market development program. 

The two Departments have identified the leadership to co-chair the Biomass 

Board that is authorized under Section 9008, Biomass Research and Development, 

of the Farm bill. This Board will not only coordinate bioenergy activities in the two 

Departments, but will coordinate Federal Government wide activities and collaborate with the newly created Biofuels Interagency Working Group mentioned above. 

FSA COMPUTERS

Question. The President’s budget includes $67.3 million to continue modernization 

and stabilization of the Farm Service Agency’s aging computer system. In your testimony you state that, ‘‘additional funding will be required in subsequent years to 

complete this process.’’ 

Can you discuss what the remaining needs will be to complete this process? 

Answer. The goal of modernization is to transform the Farm Service Agency’s 

(FSA’s) computer system to one that delivers information for the delivery of program 

benefits and information at an appropriate standard of quality and performance. 

When all the components of modernization have been fit together, FSA will have 

a streamlined information technology (IT) architecture built on business processes 

that are supported by newer, faster, more secure and more reliable web-based technologies. Given sufficient funding this goal will be achieved in fiscal year 2013. 

We greatly appreciate the $50 million made available in the Recovery Act as a 

down-payment for modernization. The primary objectives required to achieve that 

goal include finishing up stabilization efforts and completing MIDAS so that all the 

Farm Program Delivery business processes and applications may be moved off of the 

legacy system. 

Additional information is provided for the record. 

[The information follows:] 

The original estimate of total costs planned for the stabilization and MIDAS portion of modernization has not changed from the numbers we shared with Congress 

last year. Stabilization is the restoration of critical elements of FSA’s IT system 

after it began to crumble in late 2006. MIDAS is the core of the modernization effort. It is designed to streamline FSA’s farm program delivery business processes. 

The costs of these initiatives are the same as found in the ‘‘Description of Annual 

and Lifecycle Costs’’ table of the MIDAS Report transmitted on July 15, 2008. This 

report was a response to a directive in House Report 110–258 which accompanied 
103 

H.R. 3161. These costs are $305 million for MIDAS and $149 million for stabilization, which sum to a cost of $454 million. 

Most of the expenses of stabilization have been met. The remaining $20.4 million 

needed will come from a portion of the $67.3 million request. At this point, the stabilization initiative will be complete. However, while stabilization will have mitigated many of the critical weaknesses in the legacy Farm Program Delivery system, 

the system will not be modernized. 

The MIDAS initiative has received $19 million of the $50 million in Recovery Act 

funds in fiscal year 2009, so about $286 million more will be required. If the $67.3 

million request is funded, FSA will apply $46.9 million of it to MIDAS, reducing the 

remaining costs to about $239 million. 

Furthermore, we note that substantial investments will be required for additional 

modernization that is above and beyond the MIDAS effort. These additional investments would be directed toward the modernization of FSA’s commodity operation 

processes, their legacy farm loan system, and several Department-wide ‘‘Enterprise 

Systems’’ FSA shares with other agencies. These investments will also include a 

portion of the ‘‘refreshment’’ of hardware in the Common Computing Environment 

that supports the modernized web-based FSA system being developed under 

MIDAS. This refreshment involves the long needed replacement of older desktop 

PCs, telecommunications and computer network equipment at FSA’s field offices. 

QUESTIONS SUBMITTED BY SENATOR DIANNE FEINSTEIN

ASIAN CITRUS PSYLLID

Question. For the past year, the State of California, the California County Agriculture Commissioners, and citrus industry—in collaboration with APHIS—have 

been working together to curb an infestation of the Asian Citrus Psyllid, taking a 

proactive approach to prevent the spread of Huanglongbing disease. 

Will you commit the Department to working with the industry and citrus States 

to develop a California-type approach nationally? 

Answer. USDA is committed to working with industry and citrus-producing States 

to implement the most practical and effective approach to control the pest based on 

the best available science and farm practices. The initial infestations of the Asian 

citrus psyllid (ACP) in California were in areas of San Diego and Imperial Counties 

adjacent to infested areas in Mexico. These first infestations were relatively sparse 

and confined to small residential areas. This made it possible for the State to conduct an ACP suppression program, focusing on treatment of individual properties. 

More recent ACP infestations, in areas such as Los Angeles County, are much more 

extensive and are likely to pose a challenge in responding with the type of suppression program carried out in San Diego County. APHIS continues to work with the 

State, county, and the industry in California to contain and suppress the ACP populations in Los Angeles County in the most logical manner. In addition, APHIS continues to coordinate with the Government of Mexico to implement a similar program 

in the adjacent border region of Baja California to reduce the likelihood of ACP incursion into the United States from Mexico. At present we are pursuing a model 

similar to that used for Glassy Wing Sharp Shooter which has been successful in 

protecting the grape and wine industries of California from Pierce’s disease. 

In other States where ACP and Huanglongbing disease (HLB) have become established, the strategy is designed to provide safeguarding measures as part of the regulatory framework to prevent further spread of ACP and HLB. Meanwhile, USDA 

is dedicated to working with the scientific community around the world in the 

search for long-term practical solutions for citrus greening in the United States. 

Question. What support does the Department need from the industry, citrus 

States, and Congress? 

Answer. The citrus industry recognizes that they have a significant role in conducting inspections of their groves for ACP and citrus greening, and quickly reporting suspected detections to appropriate State and Federal officials. In addition, education activities conducted by the industry have emphasized the importance of complying with State and Federal regulations designed to prevent the spread of ACP 

and citrus greening. States with citrus have been cooperative in conducting surveys 

for ACP and citrus greening, and in establishing parallel quarantines in support of 

Federal regulatory actions. Industry and State and Federal governments are making significant investments in research. 

Question. What steps is the USDA taking to stop the spread of the Psyllid across 

the border from Mexico? How is USDA working with the Mexican government to 

move the ACP infestation away from the border? 
104 

Answer. USDA is working closely with Mexico, including providing technical support and funding to Mexico to conduct survey, regulatory, and suppression activities, 

in particular in areas adjacent to citrus growing areas in the United States. We believe that this has been effective in reducing the extent of the ACP infestations on 

the Mexican side of the border, and thus reduced the number of infestations in adjacent U.S. areas. In addition, APHIS has provided technical training and resources 

to Mexico, enabling that country to conduct testing for the presence of citrus greening. A high percentage of ACPs that are found are being tested for the disease. 

These efforts allowed Mexico to confirm its citrus greening infestation in Yucatan 

State and take action to prevent its spread. Pest Alerts have been provided to Department of Homeland Security, Customs and Border Patrol to heighten surveillance for ACP and HLB. 

Question. What resources are being committed by USDA to treat citrus greening 

(HLB)? What are the plans for developing resistant plants? What is the Department 

doing currently to research solutions and what are its plans for future research? 

Answer. There is currently no treatment for HLB. There is a concerted effort on 

the parts of industry, citrus States, and USDA (APHIS, the Agricultural Research 

Service, and the Cooperative State Research, Education, and Extension Service) to 

carry out activities that range from the development of strategies to suppress Asian 

citrus psyllid populations with the intended purpose of reducing disease pressure on 

the crop to the development of resistant varieties using traditional and biotechnology based approaches. Biological control is being explored in the United 

States and in Mexico. 

Question. Can you assure me that Plant Protection and Quarantine (PPQ) officers 

have adequately trained Customs and Border Patrol (CBP) inspectors to identify 

both adult and juvenile Asian citrus psyllids (ACP) on citrus trees as well as ornamental nursery plants such as Orange Jasmine that potentially host the pest? 

Answer. All plants intended for planting that enter the United States are required 

to go through one of APHIS’ 17 plant inspection stations where they are inspected 

by APHIS inspectors. CBP inspectors do not inspect live plants. However, APHIS 

has provided pest alerts to CBP for dissemination to all ports containing photographs of both juvenile and adult ACPs for use in inspecting shipments of citrus. 

CBP is focusing on citrus shipments from Mexico, where ACP is known to exist. 

However, citrus from Mexico must go through a commercial packinghouse to be eligible for import to the United States, and any psyllids present are generally removed during the washing process that the fruit goes through in the packinghouse. 

ACP is also associated with curry leaves, which are prohibited but sometimes intercepted in passenger baggage from India and other Asian countries. APHIS and CBP 

are working to ensure that such products are not overlooked, and APHIS will be 

holding a workshop near the end of calendar year 2009 for CBP inspectors on inspection processes and techniques aimed at ACP. 

CALIFORNIA DROUGHT ASSISTANCE

Question. California is facing a multi-year drought. In the San Joaquin Valley, the 

most productive agricultural area in the Nation, over half a million acres of farmland have been fallowed. Unemployment in these communities is over 40 percent. 

I commend you and Secretary Salazar for establishing a joint Federal Action 

Team on Drought, and I look forward to working with this team to assist the San 

Joaquin Valley and other drought-stricken areas of the country. 

What is the Department doing to assist the farmers and farm workers of the San 

Joaquin Valley suffering due to the drought? 

Answer. USDA has a number of programs that can provide assistance during 

drought situations. These programs include the Federal crop insurance program, the 

non-insured crop disaster assistance program, and the permanent disaster programs 

which were authorized in the 2008 Farm bill. These programs can provide compensation to producers whose farming operations are adversely impacted by 

drought. In addition, USDA programs have proven that with good planning, good 

management, and good information, farms and ranches can reduce the impacts of 

drought. For example, the USDA Joint Agricultural Weather Facility and National 

Water and Climate Center, along with the U.S. Departments of Commerce and Interior, and the National Drought Mitigation Center (NDMC) at University of Nebraska, Lincoln, help people prepare for and deal with drought. Additionally, we are 

well aware that drought impacts well beyond the boundaries of farms and ranches. 

Programs administered by our Rural Development agencies are available to assist 

communities whose drinking water supplies are impacted and can even provide assistance for drilling individual wells. 
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FROZEN FOOD SAFETY

Question. A New York Times article that appeared on May 15, entitled ‘‘For Frozen Entrees, ‘Heat and Eat’ Isn’t Enough,’’ explains that frozen food, such as pot 

pies, require additional cooking and testing on the part of the consumer before they 

are considered safe to eat. Labels on these frozen entrees require that the food be 

cooked to a uniform temperature of 165 degrees as measured by a meat thermometer. However, the author of the New York Times article found that this temperature was unreachable without burning the crust of the pot pie. 

I am very concerned that producers of frozen entrees are placing the burden of 

food safety on consumers. Consumers of these products purchase them for convenience and with the belief that they are safe to eat. 

Does the USDA’s Food Safety Inspection Service (FSIS) allow frozen entrees such 

as pot pies to contain harmful pathogens at the time of purchase by the consumer? 

What steps does the FSIS take to make sure that producers reduce or eliminate the 

presence of pathogens in frozen entrees? Does the FSIS currently conduct inspections of food labels for frozen entrees that contain raw or uncooked ingredients, to 

ensure that the labels clearly indicate that the foods may contain pathogens without 

proper preparation? 

Answer. Frozen entrees such as pot pies currently can be sold to consumers in 

either the ready-to-eat (RTE) or not-ready-to-eat (NRTE) form. RTE forms of these 

products must be free of detectable pathogens of public health concern at the time 

that the products are manufactured under Federal inspection. Such products may 

be heated by the consumer, prior to consumption, but the heating is only for palatability purposes because no pathogens are expected in the product. NRTE products 

are considered the same as a raw product (i.e., presence of microorganism, including 

pathogens, is minimized but non-detectable). Such product bears labeling identifying 

that the products are NRTE and require a full lethality treatment by the consumer 

in order to ensure safety. 

Due to illnesses associated with this type of NRTE product, the industry was informed that the Salmonella hazard needs to be better controlled and that labeling 

alone cannot be the control. Labeling of such product must be truthful and not misleading. Guidance has been issued to manufacturers of this type of product, reminding them that the consumer cooking instructions must be validated as accurate and 

practical for the intended use. 

Another type of NRTE product, i.e., NRTE stuffed poultry that appears RTE, has 

been more recently implicated in foodborne illnesses. Consequently, FSIS has been 

working with the industry on this matter and is committed to continuing this collaboration before implementing action to force more aggressive controls to ensure 

that detectable Salmonella is not present in the finished product. There is no specific timeline; however, the industry will have ample time between being provided 

the guidance on addressing and controlling Salmonella in the production of these 

products and regulatory action by the agency. 

AGRICULTURAL INSPECTORS AT HOMELAND SECURITY

Question. Thousands of agricultural products enter California every day through 

the largest international airport on the West Coast, the largest seaport in the country, and the busiest international land port of entry in the world. 

As you know, I have been very concerned about the transfer of agricultural inspections to the Department of Homeland Security. 

APHIS controlled agriculture inspections prior to March 2003. But the responsibility was transferred to The Department of Homeland Security’s Customs and Border Patrol (CBP) as part of the Homeland Security Act. Since then, reports indicate 

that the number and quality of inspections have dropped dramatically. 

Although DHS has made a concerted effort to improve the number and quality 

of inspections, I remain concerned that agricultural pest detection has taken a back 

seat to the more traditional homeland security activities of counter-gun, drug, and 

terrorism efforts. 

Are you satisfied with CBP inspections? Will you commit to working with Secretary Napolitano to improve the number and quality of these inspections for agricultural products entering our country? 

Answer. I am certainly committed to working with Secretary Napolitano to ensure 

the agricultural inspection program at ports of entry is working effectively to protect 

U.S. agriculture. I am pleased to report that staffing levels at CBP have never been 

higher than they are at this time, and that APHIS and CBP are working together 

through a variety of mechanisms to improve the Agricultural Quarantine Inspection 

(AQI) program where needed. While the program has overcome many of challenges 

it faced just after the 2003 creation of the Department of Homeland Security (such 
106 

as the large number of vacancies in the inspection force), one area that APHIS and 

CBP have targeted for improvement is the inspection of international passenger 

baggage. Through the Joint CBP–APHIS Task Force, APHIS and CBP managers 

have developed an operational action plan focused on passenger baggage inspections. 

Additionally, APHIS is holding workshops for agricultural inspectors focused on 

inspection procedures targeting specific pests. Two have already been held (focused 

on gypsy moth and Khapra beetle), and a workshop focusing on the Asian citrus 

psyllid is planned for the end of calendar year 2009. APHIS and CBP have also 

formed a joint task force on exotic fruit flies in response to the large number of detections of a variety of fruit fly species (including several not detected in the United 

States prior to this summer) in California this year. The task force will look at pathways the pest may be using and develop inspection policies and techniques to address them. The two agencies are also working to increase the number of canine 

teams deployed at ports of entry, primarily focusing on recruiting inspectors for canine teams. I believe these and other cooperative efforts demonstrate the two agencies’ commitment to working together to ensure an effective AQI program. 

DOWNER CATTLE

Question. I remain concerned about inhumane practices in slaughter houses and 

the safety of our food supply. In the fiscal year 2009 Omnibus Appropriations Act, 

Congress provided funding for 120 full-time staff dedicated solely to inspections and 

enforcement related to the Humane Methods of Slaughter Act. 

As of today, how many full-time inspectors does the Food Safety and Inspection 

Service have that are dedicated solely to enforcement of the Humane Methods of 

Slaughter Act? If you have not yet filled all 120 spots, when will these spots be 

filled? 

Answer. The fiscal year 2009 Omnibus Appropriations Act maintained the number 

of full-time positions (FTPs) dedicated to inspections and enforcement related to the 

Humane Methods of Slaughter Act (HMSA) to no fewer than 120. Because HMSA 

tasks are not performed by a single person at an establishment, FSIS instead measures in full-time equivalents (FTEs), which refers to hours spent performing these 

tasks equivalent to 80 hours a pay period, projected out to a year. As of June 2, 

2009, FSIS has measured 110 FTEs for fiscal year 2009, and estimates that there 

will be at least 140 FTEs by the end of this fiscal year. 

COUNTRY OF ORIGIN LABELS

Question. I am concerned about the increasing number of country of origin labels 

(COOL) that identify multiple countries of origin on meat products. I fear that by 

over-using labels that contain multiple countries of origin, some producers may be 

compromising the integrity of the COOL label. 

What oversight does USDA intend to conduct to assure the validity of these multiple country of origin labels and protect the value of the label for consumers? 

Answer. USDA conducts enforcement reviews at retail facilities and trace-back 

audits on individual items observed during the initial retail reviews to verify the 

accuracy of the COOL claim. USDA is now conducting the fourth year of enforcement reviews at retail facilities nationwide. The first 3 years of enforcement reviews 

were limited by statute to fish and shellfish. As of fiscal year 2009, all covered commodities must comply with the regulatory requirements for COOL. 

To ‘‘jump-start’’ COOL monitoring of all covered commodities during 2009 and 

into 2010, USDA and cooperating State agencies will conduct initial enforcement reviews at nearly 12,000 retail facilities and perform follow-up reviews at 2,000 retail 

facilities where significant non-compliances are found. In addition, USDA will conduct trace-back audits on 400 individual items observed during the initial retail reviews. The trace-back audit will track the selected covered commodity from retail 

back to the initiator of the COOL claim to verify accuracy. 

Whenever non-compliances are found at the retail or supply chain level, USDA 

notifies the retailer or supplier in writing and ensures appropriate corrective measures are implemented. Complaints filed by consumers are also investigated and, if 

appropriate, action is taken to ensure the identified retailer complies with the 

COOL regulations. 

The results of previous year review and audit findings (fish and shellfish only) are 

as follows: 

Retail Reviews—Conducted by State Cooperators or USDA Reviewers 

—Fiscal year 2006—1,159 retail stores reviewed—59 percent in full compliance; 

—Fiscal year 2007—1,657 retail stores reviewed—67.5 percent in full compliance; 

—Fiscal year 2008—2,000 retail stores reviewed—73 percent in full compliance. 
107 

Supplier Audits—Conducted by USDA Auditors 

—Fiscal year 2007—47 items audited—82 percent in full compliance; 

—Fiscal year 2008—50 items audited—95 percent in full compliance. 

USDA conducted extensive outreach prior to and during the implementation of 

the COOL regulatory requirements to facilitate compliance by retailers and their 

suppliers. For example, during the past year, USDA officials have participated in 

21 industry sponsored conference calls, 3 webinars and provided formal presentations at 33 trade association meetings and conferences. Additionally, USDA has 

resources in place to respond to telephone, e-mail and regular mail inquiries from 

producers, retailers, suppliers, consumers, media and other interested parties concerning the correct labeling of COOL covered commodities. 

ALL NATURAL LABELS FOR POULTRY

Question. Under current regulations, poultry bearing the USDA approved ‘‘natural’’ label can be pumped full of foreign substances, such as saline. These birds are 

weighed after being filled with salt water, and the consumer ends up paying for 

more chicken than they receive. This practice also raises health concerns as consumers end up eating a product that has a higher salt content than if the poultry 

had not been manipulated. Does USDA intend to revisit the ‘‘natural’’ label to rein 

in such practices? Do you believe that a chicken breast pumped full of saline is natural? 

Answer. As a required feature of labeling, the Department mandates that any addition of water and saline to poultry be included in the ingredient statement. Departmental regulations do not prohibit the addition of these components when 

truthfully labeled. 

Regarding ‘‘natural’’ labeling, the Department is charged with regulating ‘‘natural’’ claims in labeling of products under its regulatory purview. We are taking the 

necessary time to carefully consider issues related to the use of ‘‘natural’’ claims and 

to decide upon the most appropriate course of action. Even though it remains unclear as to whether or not it will be possible to reach consensus among stakeholders 

on what ‘‘natural’’ should mean, it is our goal to make every effort to at least minimize areas of differences by seeking a discrete set of alternatives. While we decide 

how to proceed, companies are still free to submit labels for consideration, and each 

label which be judged on a case-by-case basis. The Department plans to publish a 

Federal Register advanced notice of proposed rulemaking on the use of the voluntary claim ‘‘natural’’ in the fall of 2009. 

MILK INCOME LOSS CONTRACT PROGRAM

Question. As you know, the dairy industry has been exceptionally hard hit in recent months, and I want to thank you for implementing both the Milk Income Loss 

Contract program (MILC) and the Dairy Export Incentive Program (DEIP) to help 

Dairymen in California and across the country. The opening of these programs has 

been the only bright spot in what has been a very tough time for the industry. 

However, I am concerned that the MILC program favors some regions of the country over others. In California we have larger farms than in other regions of the 

country, an average of roughly 1,000 cows per farm. These large dairies make our 

State the top milk producing State in the country. 

But only the first 2.985 million pounds of milk are eligible for assistance from the 

MILC program per year. For an average California Dairy farm, this means that only 

about 15 percent of their milk output is eligible for MILC assistance. This puts California dairymen at a comparative disadvantage with other smaller-farm dairy operations across the country. 

How do you plan to address this disparity? 

Answer. The Milk Income Loss Contract program limits on eligible production are 

specified by the 2008 Farm bill. Thus, the Department has no flexibility to address 

disparity in regional impacts created by the eligible production limits in the MILC. 

However, California dairy farmers, as relatively efficient producers, do clearly and 

substantially benefit from the Dairy Product Price Support program and other 

measures the Department has taken to support the industry. So while the Department has little or no flexibility to tailor the national dairy programs to favor one 

region over another, California producers are not disadvantaged aside from the 

MILC production payment caps which affect large producers in all regions of the 

country. 
108 

REVENUE CAPS VS. INCOME CAPS

Question. It is my understanding that the President intends to begin using revenue caps, instead of the traditional income caps, to determine eligibility for direct 

farm subsidy payments. 

I am concerned that using revenue caps will unfairly disadvantage farmers of 

high revenue, low income crops such as rice and cotton. 

Can USDA structure a revenue cap to ensure that farmers of high expense crops 

will be not be prohibited from receiving direct subsidy payments? 

Answer. The President’s budget maintains the three-legged stool of farm payments, crop insurance, and disaster assistance. However, in keeping with the President’s pledge to target farm payments to those who need them the most, the budget 

proposes a hard cap on all program payments of $250,000 and to reduce crop insurance subsidies to producers and companies in the delivery of crop insurance. While 

the budget includes a proposal to phase out direct payments to the largest producers, the Department is prepared to work with Congress and stakeholders as 

these proposals are considered. 

MARKET ACCESS PROGRAM

Question. In recent years, the Market Access Program has provided California 

farmers with a vital source of monetary and technical assistance as they look to sell 

their products in foreign countries. In the 2008 Farm bill, Congress authorized $200 

million in mandatory spending for this program; however, the President proposes 

cutting this program by 20 percent in his budget. Given this program’s proven track 

record of success and widespread industry support, why was it singled out to be cut? 

Answer. The President’s budget included a series of proposed program terminations or funding reductions that would help reduce the size of the Federal deficit, 

one of which would have reduced funding for the Market Access Program. Those 

steps are necessary in order to restore fiscal discipline and lay the foundation for 

long-term growth and prosperity. They also would help to pay for other high priority 

initiatives included in the budget, such as healthcare reform, investments in education, and the development of alternative sources of energy. 

Although annual funding for the Market Access Program would be reduced, the 

program would still provide assistance for overseas market promotion of $160 million per year. In addition, other export promotion programs, such as the Foreign 

Market Development Program and the Technical Assistance for Specialty Crops Program, would continue at their currently authorized funding levels. 

QUESTIONS SUBMITTED BY SENATOR JACK REED

CATFISH INSPECTION PROGRAM

Question. Mr. Secretary, the 2008 Farm bill transferred the responsibility for inspecting catfish from the Food and Drug Administration to USDA. In doing so, the 

legislation requires that imported catfish come from countries whose inspection 

standards are equivalent to U.S. standards. It is my understanding that although 

USDA’s inspection requirements are still being developed, the department is nonetheless required by statute to ensure that a foreign government has equivalent 

standards on the date when the USDA inspection regulations are finalized if catfish 

imports are to continue from that country. As a result, there is concern among seafood importers, including one in my State, that there will not be time for foreign 

countries to achieve formalized USDA equivalence, since that process could take 

years. 

With that as background, do you believe that there is sufficient time to allow foreign governments to establish equivalent inspection regimes? 

Answer. I believe that the legislation should be administered in a fair and equitable fashion that will best achieve the public health protection purposes of the legislation. Regardless of how the department ultimately defines catfish under the 

2008 Farm bill provision, we have made it clear from the start UDSA’s willingness 

to meet with exporting countries to assist them in initiating the equivalence process. 

Further, USDA is establishing its catfish inspection program in a manner that is 

consistent with our World Trade Organization obligations. USDA will notify interested U.S. trading partners when the proposed regulation is published to ensure 

that they have the opportunity to provide comments, just as we have already provided notification of the changes in the law regarding catfish inspection. We will 

also provide our trading partners with regular updates on the progress of the rule-
109 

making process, as well as all possible technical and scientific assistance in helping 

them attain compliance and equivalence. 

Question. Are any major catfish exporting countries seeking to establish equivalent standards for catfish? If so, will they be able to establish equivalence concurrent with USDA’s new requirements? 

Answer. To date, no foreign country has requested equivalency standards for catfish. 

Question. Are you examining any temporary alternatives, such as direct inspection 

of foreign seafood operations, which might allow imports to continue while foreign 

governments try to achieve equivalent standards? 

Answer. USDA’s goals in developing the catfish proposed rule is to develop a program that maintains, if not improves, the public health protections of consumers 

and that is fair and equitable. In the proposed rule, we will lay out our thinking 

in this regard and seek public comment. 

Question. Do you believe such measures would be sufficient to ensure the safety 

of the food supply? 

Answer. The core of USDA’s mission is to protect the public health, and in no case 

would we take an action that would not be sufficient to ensure the safety of the food 

supply. 

QUESTIONS SUBMITTED BY SENATOR THAD COCHRAN

CAP-AND-TRADE LEGISLATION

Question. Mr. Secretary, I want to highlight that agriculture producers have little 

ability to negotiate prices for input costs required to produce the final product. If 

enacted, cap-and-trade legislation is likely to result in higher costs for fertilizer and 

other inputs. If input costs increase, how do you expect production agriculture to 

benefit? 

[Clerks Note: The following response is based on information available after the 

date of the hearing.] 

Answer. USDA’s preliminary analysis of costs and benefits on the agriculture sector uses energy price and other information contained in EPA’s recent analysis of 

H.R. 2454. In the short term, the economic benefits to agriculture from cap-andtrade legislation will likely outweigh the costs. In the long term, the economic benefits from offsets markets easily trump increased input costs from cap-and-trade legislation. Let me also note that we believe these figures are conservative because we 

are not able to model the types of technological change that are very likely to help 

farmers produce more crops and livestock with fewer inputs. Second, the analysis 

does not take into account the higher commodity prices that farmers will very likely 

receive as a result of enhanced renewable energy markets and retirement of environmentally sensitive lands domestically and abroad. Of course, any economic analysis such as ours has limitations. But, again, we believe our analysis is conservative, and it is quite possible farmers will actually do better if the cap-and-trade 

legislation is enacted. 

Additional information is provided for the record. 

[The information follows:] 

Looking first at the cost side, increases in fuel prices are expected to raise overall 

annual average farm expenses by about $700 million between 2012 and 2018, or 

about 0.3 percent. Annual net farm income as a result of these higher energy prices 

is expected to fall by about 1 percent. These estimates assume that in the short 

term farmers are unable to make changes in input mix in response to higher fuel 

prices so they likely overestimate the costs to farmers. Fertilizer prices will likely 

show little effect until 2025 because of the H.R. 2454 provision to help energy-intensive, trade exposed industries mitigate the burden that emissions caps would impose. 

The agriculture sector also will benefit directly from allowance revenues allocated 

to finance incentives for renewable energy and agricultural emissions reductions 

during the first 5 years of the H.R. 2454 cap-and-trade program. Funds for agricultural emissions reductions are estimated to range from about $75 million to $100 

million annually from 2012–2016. 

To evaluate the potential impact on the agricultural sector further out in time, 

we first examine a simple case that allows producers to change the crops they grow 

but not how they produce them. This approach is conservative given the observation 

that energy per unit of output has drastically declined over the last several decades. 

Nevertheless, the estimated impact of the cap-and-trade provision of H.R. 2454 im-
110 

plies a decline of annual net farm income of $2.4 billion, or 3.5 percent, in 2030 and 

$4.9 billion, or 7.2 percent, in 2048. 

These estimates are likely an upper bound on the costs, because they fail to account for farmer’s proven ability to innovate in response to changes in market conditions. Our analysis is also conservative because it does not account for revenues to 

farmers from biomass production for bioenergy. A number of studies have examined 

the effects of higher energy costs with models that allow for expected changes in 

production management practices and switching to bioenergy crops. Based on the 

analysis of Schneider and McCarl, for example, allowing for changes in input mix 

and revenues from biomass production—but without accounting for income from offsets, it is estimated that annual net farm income would increase in 2030 by about 

$0.6 billion or less than 1 percent. By 2045, annual net farm income is estimated 

to increase by more than $2 billion or 2.9 percent. 

H.R. 2454’s creation of an offset market will create opportunities for the agriculture sector to generate additional income. In particular, our analysis indicates 

that annual net returns to farmers range from about $1 billion per year in 2015– 

20 to almost $15–20 billion in 2040–50, not accounting for the costs of implementing 

offset practices. EPA has conducted its own analysis of returns from offsets that 

takes into account the costs of implementing land management practices. EPA’s 

analysis projects annual net returns to farmers of about $1–2 billion per year from 

2012–18, rising to $20 billion per year in 2050. It is important to note that EPA’s 

analysis includes revenue generated from forest management offsets while USDA’s 

does not. 

RHS RECOVERY ACT IMPLEMENTATION

Question. I understand that Rural Housing Service has a backlog of over $2.4 billion in loan requests. Mississippi has a backlog of section 502 rural housing home 

ownership loans totaling $577 million and over 700 loan requests. This is the 8th 

highest in the Nation. The economic recovery act provided an additional $1 billion 

in loan authority for section 502. What is the status of implementation of recovery 

funds? 

Answer. As of May 30, 2009, the Rural Development Single Family Housing Direct Program obligated $137.1 million of Recovery Act funding for 1,073 loans; and, 

the Guaranteed Program obligated $4.314 billion of Recovery Act funding for 36,093 

loans. Rural Development is in the process of developing and implementing an ‘‘Outreach Initiative’’ that will provide relief and assistance to field offices in processing 

single family housing loans. Authorities and funding provided by the Recovery Act 

will be utilized to hire temporary employees and deploy them in geographic regions 

based on the population living in poverty in the persistent poverty counties of those 

regions. 

Recovery Act provided an additional $1 billion in funding for the direct single 

family loan program. This funding has aided in reducing the backlog in applications 

that were maintained by the agency. However, in light of the first time home buyers 

tax credit Rural Development is currently experiencing a significant increase in demand for the single family direct loan program. The current back log totals $2.7 billion. 

AFFORDABLE RENTAL HOUSING

Question. For the last several years, Congress has provided funding for revitalization of rural rental housing projects. At the same time, there is little in the way 

of funding for newly constructed rural rental housing. What is your view of the 

proper role for Rural Housing Service in meeting the need for affordable rental 

housing for families and seniors in rural America? 

Answer. Funding provided by Congress to support revitalization efforts has helped 

us to address the processing demands of a large and rapidly aging Multi-Family 

Housing (MFH) portfolio financed by the Rural Housing Service (RHS). We would 

like to continue and expand those efforts. 

However, there is a very real demand for new affordable rental housing in rural 

areas where housing needs are not being addressed by the market or other affordable housing funding programs. RHS can use the Section 515 direct lending program, coupled with rental assistance to assist tenants with the lowest incomes, the 

Section 538 guaranteed program, which has no tenant subsidy, to serve low and 

moderate income families, and our direct farm labor housing loan and grant program (Section 514/516) coupled with rental assistance, to serve farm workers that 

support our country’s agricultural activities. These RHS MFH programs allow local 

communities to build affordable rental options into their housing infrastructure to 

keep and attract residents. 
111 

It is important to note that most new construction activity generated by RHS 

MFH programs is supplemented by funding from affordable housing partners. In 

many cases, this job creating third party capital financing would not be attracted 

to rural areas without the RHS MFH program to serve as a catalyst. In addition, 

for any affordable housing rental program to succeed in reaching those people or 

communities most in need, project based rental assistance is often a critical determinant. 

QUESTIONS SUBMITTED BY SENATOR SUSAN COLLINS

DAIRY FARMERS

Question. Dairy farmers in the northeast are really struggling. I continue to hear 

from many of Maine’s hard-working family farms who are barely surviving. Many 

of these families have been involved in the dairy industry for generations. The price 

farmers are receiving for their milk has plummeted as compared to just a year ago. 

The USDA has estimated that the average milk price will be $11.55 per hundredweight in 2009, as compared to the 2008 average price of $18.32 per hundredweight. 

The 2009 average price estimate of $11.55 would be the lowest average annual price 

received by dairy farmers since 1978. 

I understand that there are a variety of factors affecting the price of milk and 

that the USDA has recently made efforts to assist dairy farmers through existing 

support programs. I know that you authorized the transfer of dairy products, purchased under the Dairy Price Support program, to domestic feeding groups, and that 

you activated the Dairy Export Incentive Program. I also am aware that the USDA 

began making payments under the Milk Income Loss Contract program in May. 

While the steps you have taken thus far may be helpful in the short run, I am 

interested in what actions you are considering as a long-term solution. Under Section 1509 of the Farm bill, Congress authorized a blue ribbon commission to study 

Federal milk pricing system and recommend changes. 

Have you considered long-term solutions to assist the dairy industry? 

Answer. Yes, USDA is considering long-term solutions to the problems facing our 

dairy industry. [Clerk’s note: The following response is based on information available after the date of the hearing.] On August 25, 2009, we announced the establishment of a Dairy Advisory Committee to analyze the issues facing the dairy sector. 

More specifically, the purpose of the Committee is to review the issues of farm milk 

price volatility and dairy farmer profitability and to provide suggestions and ideas 

to the Secretary on how USDA can best address these issues to meet the dairy industry’s needs. 

Question. When will you create the blue ribbon commission to study Federal milk 

marketing orders? 

Answer. Establishment of the commission is subject to appropriations that have 

not been provided. 

EMPOWERMENT ZONES

Question. In January 2002, USDA Rural Development designated a large portion 

of Aroostook County, Maine, as a Round III Empowerment Zone. This designation, 

based on Aroostook County’s population out-migration, has helped provide applicants with additional points on grant applications and funds for economic development projects. 

Economic development organizations and private sector companies in Aroostook 

have joined together to help stabilize, diversify, and grow the area’s economy. This 

region’s continued designation as an Empowerment Zone and the adequate funding 

of this program are critical for making capital investments, which are prerequisites 

for business attraction in distressed communities. 

During these challenging economic times, it is particularly important that the 

Federal Government continue its commitment to our most distressed communities. 

I was disappointed that the Administration’s budget eliminates funding for Empowerment Zones. Can you explain why this effective program was cut in the budget? 

Answer. The Department of Agriculture supports rural economic development 

through community infrastructure, utility, and housing loan and grant programs. 

The small Empowerment Zone and Enterprise Community (EZ/EC) program duplicates those programs. Communities designated as Rural EZ/ECs are qualified for 

the regular rural development programs, such as the Business and Industry Guaranteed Loan Program, the Self Help Housing and Development Loans and the Rural 

Water and Waste Disposal Programs which, in many cases, have set asides in those 
112 

programs. The Budget continues to provide funding to the EZ/EC communities 

through set asides from other Rural Development programs, totaling $27.6 million. 

These set asides have been included by the Congress in previous appropriations bills 

and are expected to continue. In addition, the authority for the EZ/EC program expires December 31, 2009. 

RESOURCE CONSERVATION AND DEVELOPMENT COUNCILS (RC&DS)

Question. Can you explain why this effective program was cut in the budget? 

The USDA’s Resource Conservation and Development (RC&D) program provides 

important resources for many rural communities in Maine and around the country, 

advancing valuable local resource conservation and community development 

projects. RC&D-sponsored activities have led to more sustainable communities, better informed land use decisions, and sound management practices of our natural resources. Maine’s five RC&D councils have proven their effectiveness through a number of 

accomplishments. During fiscal year 2007, 56 new RC&D projects were approved 

and 40 projects were completed. In October 2008, the St. John Aroostook RC&D 

hosted a conference focusing on increasing energy diversity and independence and 

growing wind power generation in Maine. In addition, the Bangor RC&D has provided business development programs designed to help entrepreneurs create and 

grow a successful business. 

One of the main benefits of the RC&D program is the promotion of local economies through the leveraging of Federal dollars. According to the National Association of RC&D councils, the RC&D program is one of the Federal Government’s success stories with its ability to return $7.50 for every dollar the Federal Government 

invests to support economic development and resource protection in rural areas. 

I was disappointed that Administration’s budget eliminates funding for the RC&D 

program. 

Answer. First begun in 1962, the program was intended to build community leadership skills through the establishment of RC&D councils that would access Federal, 

State, and local programs for the community’s benefit. After 47 years, the program 

has matured to the point that this goal has been accomplished. RC&D councils 

should have developed sufficiently strong State and local ties to secure funding for 

their continued operation without Federal assistance. 

MAINE FLOOD ASSISTANCE

Question. Last spring, as a result of heavy rains and record melting snow in 

northern Maine, the St. John and Fish Rivers overflowed, causing severe flooding 

in Aroostook County, resulting in major evacuations, displacement, and damaged 

housing for many residents. In May 2008, President Bush declared this region a 

Federal disaster after this historic flooding. 

I am particularly concerned about funding needed to rebuild an apartment complex for low-income elderly and disabled residents of Fort Kent. Funding estimates 

indicate that rebuilding this critical facility will cost between $2–$3 million. 

I worked to include report language in the fiscal year 2009 Omnibus, which urged 

USDA to assist with efforts to rebuild multi-family housing in Fort Kent, Maine, 

that was destroyed by this severe flooding. 

What efforts has USDA taken to assist the community in its efforts to rebuild the 

USDA multi-family housing that was destroyed by the flood? 

Answer. We are pleased to say that funding had been approved for these critical 

rehabilitation and replacement efforts during June of this year. Currently, all parties are involved with development and construction planning. 

SUBCOMMITTEE RECESS

Senator KOHL. The subcommittee will stand in recess. 

Secretary VILSACK. Mr. Chairman, thank you for your courtesies, 

and Senator Brownback, be reassured we will find out about that 

Tufts program because the Deputy Secretary comes from Tufts. I 

am hopeful she knows all about that, and if she does not, she is 

going to find out about it. 

Senator BROWNBACK. She better. 

Secretary VILSACK. Thank you. 

[Whereupon, at 2:55 p.m., Thursday, June 4, the subcommittee 

was recessed, to reconvene subject to the call of the Chair.] 
(113) 

AGRICULTURE, RURAL DEVELOPMENT, FOOD 

AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR 

FISCAL YEAR 2010 

U.S. SENATE, 

SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS, 

Washington, DC. 

NONDEPARTMENTAL WITNESSES 

[The following testimonies were received by the Subcommittee on 

Agriculture, Rural Development, Food and Drug Administration, 

and Related Agencies for inclusion in the record. The submitted 

materials relate to the fiscal year 2010 budget request for programs within the subcommittee’s jurisdiction.] 

PREPARED STATEMENT OF THE AD HOC COALITION

Mr. Chairman, Members of the Subcommittee, this statement is respectfully submitted on behalf of the ad hoc coalition composed of the organizations listed below. 

The coalition supports sustained funding for our Nation’s food aid programs, including Titles I and II of Public Law 480, and therefore strongly opposes all proposals 

to divert funding away from these important programs. 

FOOD AID’S UNIQUE ROLE

The donation of American commodities as food aid has been the cornerstone of 

United States and global foreign assistance programs since their inception. However, food aid has evolved in important ways over the years. Food aid began as an 

outgrowth of American farm policy that generated sizeable surpluses and American 

foreign policy characterized by a Cold War competition for the hearts and minds of 

impoverished populations across the globe. Since then, American farm policy has 

evolved away from surpluses, and therefore food can no longer be mischaracterized 

as ‘‘dumping’’ of excess commodities. Indeed, the United States now purchases commodities for donation on the open market. In today’s economic climate, the need to 

provide societal stability, avoid failed States, prevent terrorist breeding grounds, 

and bolster America’s image abroad has never been more important. 

In recent years, debate in the foreign assistance community has at times questioned the role of food aid. Led by European Union trade negotiators who have complained about American food aid as a smokescreen to shield their own protectionist 

agriculture policies, some have bemoaned the potential distorting effects that food 

donations might have on local agriculture where U.S. food is disbursed. Other opponents of food aid have suggested that perhaps we would be better off if we did not 

donate commodities, but instead relied solely on agricultural development and local 

purchases. Like others in the aid community, we look forward to the day when food 

aid is no longer needed, but we are nowhere near that goal today. Our in-kind food 

aid programs are needed now more than at any time in their history. 

Donated food aid is the most reliable means of introducing food to needy communities in order to combat hunger and save lives. This is not to say that other, creative means available under the Foreign Assistance Act or elsewhere have no role. 

To the contrary, these are an important part of the aid ‘‘tool kit’’, which can and 

should be employed to further developmental goals, including food self-sufficiency 

among food aid recipients and to address unforeseeable breaks in the food aid pipe-
114 

line. But those that paint food aid as unnecessary and even harmful exhibit shortsightedness that does a great disservice to those we all strive to help. 

The need for food aid today is stronger than ever. Hunger is a powerful destabilizing force, and America faces a convergence of terrorist and other security 

threats from failed and unstable states that feed on ill will toward our Nation. The 

U.N. WFP tells us that in recent years the food insecure have been hit by a ‘‘perfect 

stone of increases in food prices coupled with export restrictions imposed by traditional regional and local food exporters. Here at home, the economy has lost 5.1 million jobs since December 2007. U.S. food aid programs not only further our humanitarian and food security goals by allowing Americans to contribute to the needy in 

a tangible way, but the programs also provide stable jobs for Americans. These programs help us get more from our aid dollars both here and abroad. 

THE SHARP DECLINE IN FOOD AID

Despite the broad, bipartisan support that food aid has long enjoyed, shipments 

declined by 71 percent, from 9.1 million tons in 1999 to a low of 2.7 million tons 

in 2007. These shipment levels are less than one-third of what they were a decade 

ago even though the most fragile communities now find themselves in the grip of 

an unprecedented food crisis. Therefore, we respectfully request that this steady erosion of food aid be reversed, and that funding be at least maintained at the $2.5 

billion level appropriated in fiscal year 2008 to ensure the continued effectiveness 

and stability of these important and historically successful programs. 

FOOD AID VERSUS CASH DONATIONS FOR ‘‘LOCAL AND REGIONAL PURCHASES’’ 

Food for Peace, which provides farm products grown in the United States to millions overseas in bags marked ‘‘From the American People,’’ is a clear and tangible 

sign of America’s concern and generosity to its recipients. This same ‘‘in-kind’’ composition generates important economic benefits to our Nation—vital jobs in many industries, farm income, markets for agriculture processors, and revenue for American 

transportation providers and ports. It also generates Federal, State, and local tax 

revenues, as well as secondary economic effects, such as farm equipment purchases 

and farm family spending in our broader economy. For these reasons, a strong domestic constituency for food aid, in good economic times and bad, has sustained 

America’s food aid programs through decades of competing funding priorities. As 

Secretary of Agriculture Vilsack said during the 2009 International Food Aid Conference, ‘‘[O]ur capacity to meet this extraordinary need [of global hunger] must 

start with a commitment to build a strong economy here in the United States. Without that strong economy, we cannot make a strong commitment to International 

Food Aid.’’ 

Furthermore, for decades American agriculture interests have provided a dependable source of high-quality nutritious food that is not always reliably available to 

local or regional markets. Given the ongoing food crisis for many nations, in terms 

of price, availability, and quality, and considering the recent actions by some foodexporting nations to halt food exports when domestic shortages occur, the amount 

and dependability of U.S.-produced food aid in Public Law 480 is crucial to our humanitarian assistance effort. 

Using American taxpayer dollars to purchase foreign agricultural commodities 

would forego the unique benefits of U.S. food aid, such as predictable food aid supply and good American jobs, when our country and food-deficit areas need them 

most. Nevertheless, additional resources have already been directed to so-called 

‘‘local and regional purchases’’: USAID was recently provided new funding of $125 

million under the Foreign Assistance Act through the International Disaster and 

Famine Assistance Account and Congress also established a $60 million CCC-funded 

USDA pilot program in the 2008 Farm Bill to examine the potential dangers and 

benefits of this approach before considering further expansion of its use in conjunction with a strong in-kind food aid program centered around American commodities. 

RESTORATION OF TITLE I/FOOD FOR PROGRESS

Recent focus has been upon Title II emergency food aid, but the Title I 

concessional sales food aid program is also an important tool in the aid ‘‘toolbox’’. 

In order to ensure that countries with the most dire need have sufficient donated 

food aid, the coalition recommends that USDA offer the Title I concessional sales 

program to countries that can afford it. Title I allows us to leverage our aid dollars, 

helping more people in need with our limited budget resources. 

To the extent that the Title I funding truly cannot be used for concessional sales, 

it may be converted to donations on full grant terms through the Food for Progress 

(‘‘FFP’’) program. There is strong demand for Title I funding channeled through 
115 

FFP: For fiscal year 2007, 100 proposals were submitted by PVOs and 16 by governments, but only 11 new proposals were approved. 

CONCLUSIONS AND RECOMMENDATIONS

Mr. Chairman, the coalition is committed to maintaining the funding for America’s food aid programs to meet humanitarian needs, enhance the potential for economic growth in recipient countries, and stimulate the economy here at home. Our 

recommendation is to increase, over time, annual food assistance with a blend of 

programs supported by direct appropriations and CCC program authorities. Specifically, the coalition respectfully recommends the following: 

—Full funding of Title II at the $2.5 billion authorized by law, which is consistent 

with the fiscal year 2008 appropriation level. 

—Title I/Food for Progress program levels should be restored to responsible levels 

so that the unique efficiencies of the program are not lost and more people can 

be fed. 

—In committee report language, the Committee should reiterate its fiscal year 

2003 directive to the administration to make greater use of existing CCC authorities to expand food aid to regions in critical need. 

Public Law 480 Food for Peace is the world’s most successful foreign assistance 

program, and has saved countless lives. Its straightforward delivery of American 

food to the hungry fills a clear and immediate need overseas, and its unique architecture has made it a successful program here at home that has endured for over 

fifty years. While we support creative efforts to address the root causes of hunger, 

we cannot emphasize enough that now, more than ever, the world needs Public Law 

480 food aid. 

Thank you, Mr. Chairman. 

America Cargo Transport Corp. 

American Maritime Congress 

American Maritime Officers 

American Maritime Officers’ 

Service American Peanut Council 

American Soybean Association 

Global Food and Nutrition Inc. 

International Organization of Masters, 

Mates & Pilots 

Liberty Maritime Corporation 

Maersk Line, Ltd. 

Marine Engineers’ Beneficial Association 

Maritime Institute for Research and 

Industrial Development 

National Association of Wheat Growers 

National Corn Growers Association 

National Council of Farmer Cooperatives 

National Oilseed Processors Association 

National Potato Council 

Seafarers International Union 

Sealift, Inc. 

Tosi Maritime Consultants, LLC 

Transportation Institute 

United Maritime Group, LLC 

U.S. Dry Bean Council 

U.S. Dry Pea & Lentil Council 

U.S. Wheat Associates, Inc. 

USA Rice Federation 

PREPARED STATEMENT OF THE AMERICAN FARM BUREAU FEDERATION

The American Farm Bureau Federation (AFBF) has identified five general areas 

for increased emphasis and funding for United States Department of Agriculture 

(USDA) programs in the fiscal year 2010 agriculture spending bill. They are: 

—Programs that strengthen rural communities; 

—Programs that improve USDA efficiency; 

—Programs that enhance and improve food safety and protection; 

—Programs that expand export markets for agriculture; and 

—Programs that insure the availability of crop protection tools for food production. 

Within these categories, we would like to call your attention to specific programs 

deserving of your support. 

Programs that Strengthen Rural Communities 

The lack of high-speed, modern telecommunications systems in rural America 

hinders its residents’ access to educational, medical and business opportunities, and 

therefore the economic growth of rural America. We support $1.3 billion for loans 

and grants administered by the Rural Utilities Service to increase rural broadband 

capacity and telecommunications services and to fund the Distance Learning and 

Telemedicine Program. 

Rural entrepreneurs often lack access to the capital and technical assistance necessary to start new businesses. These new ventures are needed for rural communities to sustain themselves and contribute to our national economy. AFBF supports 

funding for USDA Rural Development (RD) programs that foster new business de-
116 

velopment in rural communities. These programs include Value-Added Agricultural 

Production Grants, Business and Industry Direct and Guaranteed Loans, and the 

Rural Microentrepreneur Assistance Program. 

Many rural communities lack access to the tax base necessary to provide modern 

community facilities like fire stations. We support funding for RD’s Community Facility Direct and Guaranteed Loans, which finance the construction, enlargement or 

improvement of essential community facilities in rural areas and towns with populations of less than 20,000. 

Renewable energy production holds great promise as a means to help America’s 

farmers and rural communities contribute to our national economy and enhance our 

national security. We support increasing funding for the Renewable Energy and Energy Efficiency Program (REEP) by $250 million. REEP offers grants, guaranteed 

loans and combination grant/guaranteed loans to help agricultural producers and 

rural small businesses purchase and install renewable energy systems and make energy efficiency improvements in rural areas. 

The Revolving Fund (RFP) Grant Program helps communities acquire safe drinking water and sanitary, environmentally sound waste disposal facilities. With dependable water facilities, rural communities can attract families and businesses 

that will invest in the community and improve the quality of life for all residents. 

We support funding for this important program. 

AFBF supports funding for and opposes any effort to eliminate the Resource Conservation and Development program. This vital program supports economic development and resource protection. This program, in cooperation with rural development 

councils, helps local volunteers create new businesses, form cooperatives, develop 

marketing and agri-tourism activities, improve water quality and flood control, improve leadership and other business skills and implement renewable energy 

projects. 

We support full funding for Agriculture in the Classroom, a national grassroots 

program coordinated by the USDA. This worthy program helps students gain a 

greater awareness of the role of agriculture in the economy and society, so that they 

may become citizens who support wise agricultural policies. 

Programs that Improve USDA Efficiency 

Farm Bureau strongly supports providing an additional $250 million to USDA to 

improve computer technology in the Farm Service Agency (FSA). FSA currently operates on the oldest technology system within USDA and one of the oldest systems 

in the entire Federal Government. These outdated systems create enormous inefficiencies throughout the department, and it is unclear how long these antiquated 

systems can continue to support increasingly complex farm programs. Systems 

across agencies under USDA jurisdiction cannot communicate with each other, 

which could lead to improper payments and often requires duplicative paperwork 

and additional labor hours. Upgrading FSA computer technology now will lead to 

greater efficiencies down the road and could prevent a future system failure. 

Programs that Enhance and Improve Food Safety and Protection 

Americans spend more than $1 trillion annually on food—nearly half of it in restaurants, schools and other places outside the home. Consumers have a reasonable 

expectation that the food products they buy are safe. The continued safety of food 

is crucial to consumers, as well as production agriculture and the food industry. 

AFBF believes that sufficient, reliable Federal funding for the government’s food 

and feed safety and protection functions is vital to this effort. 

Therefore, we recommend that funding be increased for food protection at the 

Food and Drug Administration (FDA) and at the Food Safety and Inspection Service 

(FSIS) and directed to: 

—Increased education and training of inspectors; 

—Additional science-based inspection, targeted according to risk; 

—Research and development of scientifically based rapid testing procedures and 

tools; 

—Accurate and timely responses to outbreaks that identify contaminated products, remove them from the market and minimize disruption to producers; and 

—Indemnification for producers who suffer marketing losses due to inaccurate 

government-advised recalls or warnings. 

We also support authorized funding of $2.5 million for the Food Animal Residue 

Avoidance Databank (FARAD). FARAD aids veterinarians in establishing sciencebased recommendations for drug withdrawal intervals, critical for both food safety 

and animal health. No other government program provides or duplicates the food 

safety information FARAD provides to the public. Without the critical FARAD pro-
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gram, producers may be forced to euthanize animals or dispose of meat, milk and 

eggs due to the lack of withdrawal information. 

Programs that Expand Export Markets for Agriculture 

AFBF supports funding at authorized levels for: 

—Public Law 480 programs which serve as the primary means by which the 

United States provides needed foreign food assistance through the purchase of 

U.S. commodities. In addition to providing short-term humanitarian assistance, 

the program helps to develop long-term commercial export markets. 

—The International Food for Education Program which is an effective platform 

for delivering severely needed food aid and educational assistance. 

The Market Access Program, the Foreign Market Development Program, the 

Emerging Markets Program and the Technical Assistance for Specialty Crops program are effective export development and expansion programs. These programs 

have resulted in record increases in demand for U.S. agriculture and food products 

abroad and should be fully funded. 

As trade increases between countries, so too does the threat of new invasive and 

noxious pests that can destroy America’s agricultural and natural resources. Therefore, we support full funding for the following Animal Plant Health Inspection Service (APHIS) programs: 

—The APHIS Plant Protection and Quarantine personnel and facilities, especially 

the plant inspection stations, are necessary to protect U.S. agriculture from 

costly pest problems that enter the United States from foreign lands. 

—APHIS trade issues resolution and management activities are essential for an 

effective response when other countries raise pest and disease concerns (i.e., 

sanitary and phytosanitary measures) to prohibit the entry of American products. APHIS must be active at U.S. ports and in overseas locations to monitor 

pest and disease conditions, negotiate trading protocols and to intervene when 

foreign officials wrongfully prevent the entry of American imports. 

—APHIS Biotechnology Regulatory Services (BRS) play an important role in overseeing the permit, notification and deregulation process for products of biotechnology. BRS personnel and activities are essential to ensure public confidence and international acceptance of biotechnology products. 

Full funding for the Foreign Agricultural Service (FAS) is urgently needed to 

maintain services in an agency that has been significantly depleted in recent years. 

We urge continued support for the Office of the Secretary for cross-cutting trade negotiations and biotechnology resources. 

The U.S. Codex Office is essential to developing harmonized international standards for food and food products. Codex standards provide uniformity in food rules 

and regulations by allowing countries to adopt similar levels of safety protection for 

consumers while concurrently facilitating transparency in food trade. 

Programs that Insure the Availability of Information on Crop Protection Tools Used 

for Food Production 

Farmers need access to reliable and affordable crop protection chemicals. Farm Bureau supports $8.4 million be provided to the National Agricultural Statistical 

Service (NASS), specifically for the continuation of agricultural chemical-use surveys 

for fruits, vegetables, floriculture and nursery crops. NASS surveys provide current 

and relevant data about the use of agricultural chemicals involved in the production 

of food, fiber and various horticultural products. The information collected helps 

USDA to conduct reliable analysis of product use and EPA to characterize the potential theoretical risks associated with agricultural chemical products. Only with 

reliable data can USDA and EPA accurately access the economic benefits of agricultural chemicals and make responsible decisions about product registration. 

PREPARED STATEMENT OF THE AMERICAN HONEY PRODUCERS ASSOCIATION, INC. 

Chairman Kohl and Members of the Subcommittee, my name is Kenneth Haff, 

and I currently serve as President of the American Honey Producers Association 

(‘‘AHPA’’). I am pleased today to submit the following statement on behalf of the 

AHPA, a national organization of commercial beekeepers actively engaged in honey 

production and crop pollination throughout the country. The purpose of this statement is to bring to your attention the continued threats faced by American beekeepers and the billions of dollars in U.S. agriculture that rely upon honeybee pollination services. With those threats in mind, we respectfully request an appropriation of at least $20 million to combat CCD and to conduct other essential honeybee 

research through the ARS and other agencies at the Department of Agriculture, as 

provided for in the 2008 Farm Bill. 
118 

As I speak to you today, U.S. beekeepers are facing the most extraordinary of 

challenges. Colony Collapse Disorder (‘‘CCD’’) has continued to ravage bee colonies 

across the United States, moving from one hive to another in unpredictable patterns. The result has been the death of up to 90 percent of the bee colonies in affected apiaries. In early 2007, the National Research Council at the National Academy of Sciences characterized the beekeeping industry as being in ‘‘crisis mode’’— 

a point echoed and re-emphasized in last year’s USDA action plan regarding honeybee threats. Hundreds of news articles and many in-depth media reports have 

continued to chronicle the looming disaster facing American beekeepers and the producers of over 90 fruit, vegetable and fiber crops that rely on honeybee pollination. 

However, despite extensive and coordinated work by experts from government, academia and the private sector, the definitive causes of and solutions for CCD have 

yet to be identified. 

The emergence of CCD shines a bright light on the inadequacies of current honeybee research, particularly on the lack of capacity to address new challenges and 

to take long-term steps to assure honeybee health. In saying this, we do not mean 

to diminish the vital, ongoing work of ARS and other honeybee scientists. They do 

their job and they do it very well. In recent years, however, honeybee research has 

become largely confined to four ARS laboratories that provide the first line of defense against exotic parasitic mites, Africanized bees, viruses, brood diseases, pests, 

pathogens and other conditions. Universities and the private sector have substantially scaled back their efforts due to a lack of available funds. Moreover, ARS laboratories lack sufficient resources even for current honeybee research priorities. For 

example, we understand that ARS currently lacks funds even to test high priority 

CCD samples that ARS scientists have already collected. 

In past fiscal years, this Subcommittee has supported the beekeeping industry 

through funding for agricultural research activities. As you know, in the fiscal year 

2003 cycle, the Subcommittee rejected a proposal that would have resulted in the 

elimination of three ARS laboratories that are indispensable to the survival of our 

industry. Again, in the fiscal year 2009 omnibus appropriations bill, Congress preserved funding for the Weslaco, Texas ARS research facility despite a recommendation in President Bush’s fiscal year 2009 budget proposal to close that facility. Those 

were wise decisions. Without these labs, the American honeybee may not have survived the various above-mentioned threats, and the infrastructure would not exist 

today upon which an aggressive research campaign may continue to be built. 

For fiscal year 2009, Congress appropriated an additional $800,000 in research 

funding specifically designated to combat CCD. We appreciate and support the increased funding for CCD research, and we sincerely thank this Subcommittee for 

its diligent attention to the crises before us. However, we believe strongly that an 

increase in $800,000 does not come close to meeting the growing demands imposed 

by CCD and other threats to honeybee health. Instead, to meet the needs of the 

American beekeeper and to stave off a pending agricultural crisis for growers and 

consumers, we respectfully urge the Subcommittee to appropriate $20 million in 

new research funds dedicated toward CCD and other honeybee health research 

projects. As you know, the 2008 Farm Bill included an authorization of $100 million 

over five years for such initiatives. A $20 million appropriation in fiscal year 20010 

would reflect that authorization, and would provide government, academic and private sector researchers with the vital resources needed to combat CCD and other 

emerging threats and assure long-term honeybee health. Such funding would be a 

prudent investment in the U.S. farm infrastructure, which, along with U.S. consumers, derives tens of billions of dollars of benefit directly from honeybee pollination. Finally, in addition to the new and significant additional funding proposed 

for CCD research needs, we specifically suggest increased funding in the amount of 

at least $250,000 for promising honeybee genome research at the ARS laboratory 

in Baton Rouge. Genome research is likely to be central to resolving mysterious 

threats such as CCD and to ensuring bee health and productivity for generations 

to come. 

THE IMPORTANCE OF HONEYBEES TO U.S. AGRICULTURE

Honeybees are an irreplaceable part of the U.S. agricultural infrastructure. Honeybee pollination is critical in the production of more than 90 food, fiber, and seed 

crops and directly results in more than $15 billion in U.S. farm output. The role 

of pollination is also vital to the health of all Americans given the dietary importance of fruit, vegetables and nuts, most of which are dependent on pollination. 

Honeybees are necessary for the production of such diverse crops as almonds, apples, oranges, melons, blueberries, broccoli, tangerines, cranberries, strawberries, 
119 

vegetables, alfalfa, soybeans, sunflower, and cotton, among others. In fact, honeybees pollinate about one-third of the human diet. 

The importance of this pollination to contemporary agriculture cannot be understated. In fact, the value of such pollination is vastly greater than the total value 

of honey and wax produced by honeybees. More than 140 billion honeybees, representing 2 million colonies, are transported by U.S. beekeepers across the country 

every year to pollinate crops. 

The importance of honeybees—and the U.S. honey industry which supplies the 

honeybees for pollination—is illustrated by the pollination of California’s almond 

crop. California grows 100 percent of the Nation’s almond crop and supplies 80 percent of the world’s almonds. Honeybees are transported from all over the Nation to 

pollinate California almonds, which are the largest single crop requiring honeybee 

pollination. More than one million honeybee hives are needed to pollinate the 

600,000 acres of almond groves that line California’s Central Valley. Thus, nearly 

half of the managed honey-producing colonies in the United States are involved in 

pollinating California almonds in February and March. 

Many other U.S. agriculture producers require extensive honeybee pollination for 

their crops, including blueberry, avocado, and cotton growers. Cattle and farmraised catfish industries also benefit from honeybee pollination, as pollination is important for growing alfalfa, which is fodder for cattle and farm-raised fish. As 

OnEarth magazine has noted, the fate of California’s almond crop rests ‘‘on the slender back of the embattled honeybee.’’ 

THREATS TO U.S. HONEYBEES

Since 1984, the survival of the honeybee has been threatened by continuing infestations of mites, pests and other conditions for which appropriate controls must continually be developed by scientists at the four ARS laboratories and other highly 

qualified research institutions. These longstanding and worsening infestations have 

caused great strain on the American honeybee to the point where some U.S. honey 

producers have felt the need—for the first time in over 80 years—to import bees 

from New Zealand and Australia for pollination. Ironically, scientists and industry 

leaders have since concluded that there is likely a correlation between the introduction of foreign bees and the emergence of CCD, the newest and greatest challenge 

to the survival of American honeybees. 

However, the specific cause of CCD and treatments for it remain elusive to both 

beekeepers and scientists. The research is complex, as there are a wide range of factors that—either alone or in combination—may be causes of this serious condition. 

Areas for research include the stress from the movement of bees to different parts 

of the country for extensive commercial pollination, the additional stress of pollinating crops, such as almonds, that provide little honey to the bees, and the impact 

of certain crop pesticides and genetic plants with altered pollination characteristics. 

Continuing infestations of the highly destructive Varroa mite, combined with other 

pests and mites, are also thought to compromise the immune systems of bees and 

may leave them more vulnerable to CCD. At the same time, researchers will need 

to focus on the many reported instances in which otherwise healthy, pest-free, stationary bee colonies are also suffering collapse or problems with reproduction. 

While researchers continue in their exhaustive effort to isolate the specific causes 

of CCD, the AHPA strongly urges the Congress to work with the Department of Agriculture to ensure that exotic bees and the threats they pose are restricted from 

importation into the United States. Under current law, the Department of Agriculture has the duty to refuse a shipment’s entry into the United States where the 

export certificate identifies a bee disease or parasite of concern to the United States 

or an undesirable species or subspecies of honeybee, including the Oriental honeybee 

or ‘‘Apis cerana’’ (7 CFR § 322.6(a)(2) (2004)). In the case of Australian honeybees, 

officials in that country have detected the presence of the Apis cerana honeybee 

throughout their country, a species known to harbor parasitic mites and possibly viruses that do not currently exist in the United States. At the time of discovery, officials tracked a large number of Apis cerana bees, indicating that the species had 

been in Australia for some time without detection. While Australian officials claim 

to have quarantined these bees and destroyed hives known to contain them, we 

have heard reports that new discoveries have taken place since such claims by Australian officials, indicating an insufficient capacity by Australian officials to accurately assess risks. AHPA believes that this development allows no other conclusion 

but for the Department to suspend entry of Australian honeybees. 
120 

ONGOING AND NEW CRITICAL RESEARCH

AHPA, other industry officials, and leading scientists believe that an important 

contributing factor in the current CCD crisis is the longstanding, substantial under 

funding of U.S. bee research. In recent years, the Federal Government has spent 

very modest amounts at each ARS Honeybee Research Laboratory—for a sector that 

directly contributes $15 billion per year to the U.S. farm economy. Worse still, funding amounts have not been increased to account for growing bee health concerns. 

USDA honeybee researchers remain under funded. As noted above, current funding 

shortages have caused important CCD-related bee samples to go untested. Additionally, despite their ability to provide significant and innovative new research on 

emerging bee threats, researchers in the academic and private sectors also lack the 

necessary financial resources for these vital tasks. With the emergence of CCD, 

there is a serious gap between the threats faced by U.S. honeybees and the capacity 

of our researchers to respond. Closing this gap will require significant new resources. It is estimated that each new scientist, technician and the support materials that they need will cost an additional $500,000 per year. 

To address these challenges, the AHPA respectfully requests an appropriation of 

at least $20 million to combat CCD and conduct other essential honeybee research. 

These funds should be allocated in accordance with authorizations provided in the 

2008 Farm Bill. Specifically, the funds should be divided among the following Department of Agriculture agencies and programs: (1) the four ARS Bee Research Laboratories for new personnel, facility improvement, and additional research; (2) the 

Animal and Plant Health Inspection Service to conduct a nation-wide honeybee pest 

and pathogen surveillance program; (3) the ARS Area Wide CCD Research Program 

divided evenly between the Beltsville, MD and the Tucson, Arizona research laboratories to identify causes and solutions for CCD in affected States; (4) the Cooperative State Research, Education, and Extension Service at the Department of Agriculture to fund extension and research grants to investigate the following: honey bee 

biology, immunology, and ecology; honey bee genomics; native bee crop pollination 

and habitat conservation; native bee taxonomy and ecology; pollination biology; sublethal effects of insecticides, herbicides, and fungicides on honey bees, native pollinators, and other beneficial insects; the effects of genetically-modified crops, including the interaction of genetically-modified crops with honey bees and other native 

pollinators; honey, bumble, and other native bee parasites and pathogens effects on 

other native pollinators; and (5) the additional ARS research facilities in New York, 

Florida, California, Utah, and Texas for research on honey and native bee physiology, insect pathology, insect chemical ecology, and honey and native bee toxicology. 

Since the beekeeping industry is too small to support the cost of needed research, 

publicly-funded honeybee research by the four ARS bee laboratories is absolutely 

key to the survival of the U.S. honey and pollination industry. For example, the pinhead-sized Varroa mite is systematically destroying bee colonies and prior to CCD 

was considered the most serious threat to honeybees. Tracheal mites are another 

contributing factor to the loss of honeybees. Tracheal mites infest the breathing 

tubes of adult honeybees and also feed on the bees’ blood. The mites essentially clog 

the bees’ breathing tubes, blocking the flow of oxygen and eventually killing the infested bees. 

The industry is also plagued by a honeybee bacterial disease that has become resistant to antibiotics designed to control it, and a honeybee fungal disease for which 

there is no known treatment. These pests and diseases, especially Varroa mites and 

the bacterium causing American foulbrood, are now resistant to chemical controls 

in many regions of the country. Further, we have seen that these pests are building 

resistance to newly-developed chemicals more quickly than in the past, thereby limiting the longevity of chemical controls. 

As previously mentioned, the cause or causes of CCD are unknown. Thus, pest, 

viral and bacterial disease research takes on added significance. First, pest, viral 

and bacterial disease research may itself provide insight into the discovery of CCD’s 

root causes. Second, whether pests and bacterial diseases are directly a factor in 

CCD or not, they nonetheless continue to threaten bee population health and vitality. Given CCD’s particularly devastating impact on bee populations, even greater 

emphasis must be placed on mitigating known threats in order to achieve the overall goal of ensuring adequate honey production and pollination capacity. 

In addition to pest and bacterial disease research, the sequencing of the honeybee 

genome in 2006 at Baylor University has opened the door to creating highly effective solutions to bee health and population problems via marker-assisted breeding. 

Marker-assisted breeding would permit the rapid screening of potential breeders for 

specific DNA sequences that underlie specific desirable honeybee traits. The 
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sequenced honeybee genome is the necessary key that will allow scientists to discover the important DNA sequences. Additional funding for the ARS research laboratory at Baton Rouge will assure that this critically important work goes forward. 

Because of the sequenced honeybee genome, it is now possible to apply molecular 

biological studies to the development of marker-assisted breeding of honeybees. 

Marker-facilitated selection offers the first real opportunity to transform the beekeeping industry from one that has been dependent upon a growing number of expensive pesticides and antibiotics into an industry that is free of chemical inputs 

and that is economically viable in today’s competitive global marketplace. Additionally, this new sequencing capacity may prove central to identifying both the causes 

of and solutions to CCD. New pathogens have recently been identified in the United 

States that are thought to be associated with CCD. Genetic research can be utilized 

to determine whether a comparative susceptibility to such pathogens exists among 

various bee populations, and if so, can serve to facilitate breeding with enhanced 

resistance. 

The four ARS Honeybee Research Laboratories work together to provide research 

solutions to problems facing businesses dependent on the health and vitality of honeybees. The key findings of these laboratories are used by honey producers to protect their producing colonies and by farmers and agribusinesses to ensure the efficient pollination of crops. Each of the four ARS Honeybee Research Laboratories 

(which are different in function from the ARS Wild Bee Research Laboratory at 

Logan, Utah) focuses on different problems facing the U.S. honey industry and undertakes research that is vital to sustaining honey production and assuring essential pollination services in this country. Furthermore, each of the four ARS Honeybee Research Laboratories has unique strengths and each is situated and 

equipped to support independent research programs which would be difficult, and 

in many cases impossible, to conduct elsewhere. Given the multi-factor research capacity needed to address the scourge of CCD, it is important that each research laboratory is permitted to continue and expand upon its unique strengths. 

And while to date the four ARS Research Laboratories have been the backbone 

of American Honeybee research, we do not believe that those four facilities alone— 

even when fully funded—will have the capacity to meet today’s research needs. This 

is why last year, after analyzing the new and serious threats to U.S. honeybees, 

Congress, representatives of the farm sector and leading researchers developed the 

research priorities that were incorporated into both the House and Senate versions 

of the Farm Bill and in separate House and Senate pollination legislation. In addition to increased resources for ARS research, these experts pressed for new funding, 

through CSREES, for government, academic and private sector research. They also 

urged new bee surveillance programs through the Animal and Plant Health Inspection Service to address the alarming lack of accurate information about the condition of U.S. bee colonies. 

One particularly effective way of adding needed capacity and innovative expertise 

in the effort to ensure honeybee health would be to reinvigorate private sector and 

university bee research initiatives. For many years, these sectors played a vital role 

in honeybee research, and many leading universities have significant bee research 

capabilities. In recent years, non-federal agency research has substantially declined 

due to a lack of support for such initiatives. Funding the 2008 Farm Bill authorization of $10.26 million for the Department of Agriculture’s Cooperative State Research, Education, and Extension Services (CSREES) would go a long way toward 

achieving this goal. 

CSREES is tasked with advancing knowledge for agriculture by supporting research, education, and extension programs. Funds may be channeled through the 

Department to researchers at land-grant institutions, other institutions of higher 

learning, Federal agencies, or the private sector. The requested funding for CSREES 

would provide important flexibility in allocating badly needed Federal dollars among 

government, private sector and university researchers. The recipients would provide 

more widespread research on honeybee biology, immunology, ecology, and genomics, 

pollination biology, and investigations into the effects on honeybees of potentially 

harmful chemicals, pests, other outside influences, and genetically modified crops. 

The result of such funds would be to ensure flexible financing with a comprehensive 

plan for battling CCD, pests, and other ongoing and future honeybee threats. 

Additionally, the same coalition of experts identified a need for a honeybee pest 

and pathogen surveillance program. Although significant data exists on American 

honey production, comparably less and lower quality data exists on beekeepers and 

bees. Providing $2.31 million under the 2008 Farm Bill authorizations to the Animal 

and Plant Health Inspection Service at the Department of Agriculture would allow 

the Department to utilize such data to better respond to pest and disease outbreaks, 

and to compile data that may better enable prediction of new threats. Given the 
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roughly $15 billion added to the U.S. farm economy each year by honeybees, this 

is certainly a worthwhile investment in the honeybee and pollinator industry. 

INDUSTRY WORKFORCE VULNERABILITIES

Beekeeping is a highly skilled trade that requires extensive training before workers are able to handle, monitor, and treat bees. For nearly ten years, American beekeepers have relied heavily on Nicaraguan workers hired through the H–2A visa 

program to staff complex honey production and pollination operations. 

Commercial beekeeping has become increasingly challenging in recent years with 

the emergence of new diseases and pests that threaten bee health, including American foul brood, tracheal and varroa mites, chalkbrood, and most recently, Colony 

Collapse Disorder (CCD). Nicaraguan H–2A beneficiaries are trained to identify 

these threats and to treat the bees skillfully and appropriately. Additionally, commercial beekeepers place hives on farms and ranches in hundreds of locations 

throughout multiple towns and counties, often in hard-to-find back road areas. 

Training new workers to find these hives and to comply with the requirements of 

landowners can alone take months. Finally, Nicaraguan workers are trained on a 

wide variety of equipment necessary to the industry, including honey extractors, 

forklifts, and large trucks used to haul equipment and bees to and from warehouses 

and apiaries. 

Unfortunately, on December 18, 2008, the Department of Homeland Security published a final rule that changed existing law so that H–2A visa ‘‘petitions may only 

be approved for nationals of countries that the Secretary of Homeland Security has 

designated as participating countries.’’ The list, published without advance warning 

names 28 ‘‘participating countries’’, including Belize, Costa Rica, El Salvador, Guatemala, and Honduras. Absent from the list is Nicaragua. And although the rule 

provides the Secretary of Homeland Security with discretionary authority to approve 

nationals from non-participating countries if it is ‘‘in the U.S. interest’’, this discretion has yet to be exercised with respect to beekeeper petitions. Without sufficient 

guidance on the ‘‘U.S. Interest’’ test, the effect will be to ensure that no Nicaraguan 

worker petitions are approved in 2009, forcing some beekeepers to close down operations. 

The AHPA does not wish to question broader national security or immigration 

policy rationales for restricting the participating country list. However, in this instance, Nicaraguan workers have provided an invaluable service to America’s honey 

production and pollination industries for nearly ten years. In all cases, the workers 

have returned to their home country at the end of the pollination season and the 

beekeepers who employ them have taken great strides to ensure that they comply 

with immigration and labor laws in petitioning the government for H–2A visas. Refusing approval this year will seriously limit America’s pollination capacity, directly 

threatening $15 billion in U.S. agricultural interests. 

CONCLUSION

In conclusion, we wish to thank you again for your past support of honeybee research and for your understanding of the critical importance of these ARS laboratories. By way of summary, in fiscal year 2010, the American Honey Producers Association strongly encourages at least $20 million in new funding for CCD and other 

honeybee research spread among the four ARS Honeybee Research Laboratories, 

other ARS research facilities across the country, the Cooperative State Research, 

Education, and Extension Service at the Department of Agriculture, and the Animal 

and Plant Health Inspection Service. AHPA also opposes importation of Australian 

honeybees and unnecessary denial of H–2A workers from Nicaragua. Only through 

critical research can we have a viable U.S. beekeeping industry and continue to provide stable and affordable supplies of bee-pollinated crops, which make up fully onethird of the U.S. diet. I would be pleased to provide answers to any questions that 

you or your colleagues may have. 

PREPARED STATEMENT OF THE AMERICAN INDIAN HIGHER EDUCATION CONSORTIUM

Mr. Chairman and Members of the Subcommittee, on behalf of the American Indian Higher Education Consortium (AIHEC) and the 32 Tribal Colleges and Universities (TCUs) that compose the list of 1994 Land Grant Institutions, thank you for 

this opportunity to share our funding requests for fiscal year 2010. 

This statement is presented in three parts: (a) a summary of our fiscal year 2010 

funding recommendations, (b) a brief background on Tribal Colleges and Universities, and (c) an outline of the 1994 Tribal College Land Grant Institutions’ plan 
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for using our land grant programs to fulfill the agricultural potential of American 

Indian communities, and to ensure that American Indians have the skills and support needed to maximize the economic potential of their resources. 

SUMMARY OF REQUESTS

We respectfully request the following funding levels for fiscal year 2010 for our 

land grant programs established within the USDA Cooperative State Research, 

Education, and Extension Service (CSREES) and the Rural Development mission 

area. In CSREES, we specifically request: $5.0 million for the 1994 Institutions’ 

competitive extension grants program; $3.0 million for the 1994 Institutions’ competitive research grants program; $3.342 million for the higher education equity 

grants; $12 million payment into the Native American endowment fund; and in the 

Rural Development—Rural Community Advancement Program (RCAP), that $5.0 

million be provided for each of the next 5 fiscal years for the TCU Essential Community Facilities Grants Program. The grants help to address the critical facilities 

and infrastructure needs at the colleges to increase our capacity to participate fully 

as land grant partners. 

BACKGROUND ON TRIBAL COLLEGES AND UNIVERSITIES

The first Morrill Act was enacted in 1862 specifically to bring education to the 

people and to serve their fundamental needs. Today, 147 years after enactment of 

the first land grant legislation, the 1994 Land Grant Institutions, as much as any 

other higher education institutions, exemplify the original intent of the land grant 

legislation, as they are truly community-based institutions. 

The Tribal College Movement was launched in the past 40 years with the establishment of Navajo Community College, now Dine ́ College, serving the Navajo Nation. Rapid growth of the TCU Movement soon followed, primarily in the Northern 

Plains region. In 1972, six tribally controlled colleges established the American Indian Higher Education Consortium to provide a support network for member institutions. Today, AIHEC represents 37 Tribal Colleges and Universities—32 of which 

compose the current list of 1994 Land Grant Institutions located in 12 States. Our 

institutions were created specifically to serve the higher education needs of American Indian students in Indian Country. They serve many thousands of Indian fulland part-time students and community members from over 250 federally recognized 

tribes. 

The 1994 Land Grant Institutions are accredited by independent, regional accreditation agencies and like all institutions of higher education, must undergo stringent 

performance reviews to retain their accreditation status. TCUs serve as community 

centers by providing libraries, tribal archives, career centers, economic development 

and business centers, public meeting places, and child and elder care centers. Despite their many obligations, functions, and notable achievements, TCUs remain the 

most poorly funded institutions of higher education in this country. The vast majority of the 1994 Land Grant Institutions is located on Federal trust territory. Therefore, states have no obligation, and in most cases, provide no funding to TCUs. In 

fact, most States do not even provide funds to our institutions for the non-Indian 

state residents attending our colleges, leaving the TCUs to assume the per student 

operational costs for non-Indian students enrolled in our institutions, accounting for 

approximately 20 percent of our student population. This is a significant financial 

commitment on the part of TCUs, as they are small, developing institutions and 

cannot, unlike their state land grant partners, benefit from economies of scale— 

where the cost per student to operate an institution is reduced by the comparatively 

large size of the student body. 

As a result of 200 years of Federal Indian policy—including policies of termination, assimilation and relocation—many reservation residents live in conditions of 

poverty comparable to those found in Third World nations. Through the efforts of 

Tribal Colleges and Universities, American Indian communities are availing themselves of resources needed to foster responsible, productive, and self-reliant citizens. 

It is essential that we continue to invest in the human resources that will help open 

new avenues to economic development, specifically through enhancing the 1994 Institutions’ land grant programs, and securing adequate access to information technology. 

1994 LAND GRANT PROGRAMS—AMBITIOUS EFFORTS TO REACH ECONOMIC POTENTIAL

In the past, due to lack of expertise and training, millions of acres on our reservations lie fallow, under-used, or have been developed through methods that have 

caused irreparable damage. The Equity in Educational Land Grant Status Act of 

1994 is addressing this situation and is our hope for future advancement. 
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Our current land grant programs remain small, yet very important to us. It is 

essential that American Indians explore and adopt new and evolving technologies 

for managing our lands. With increased capacity and program funding, we will become even more significant contributors to the agricultural base of the nation and 

the world. 

Competitive Extension Grants Programs.—That The 1994 Institutions’ extension 

programs strengthen communities through outreach programs designed to bolster 

economic development; community resources; family and youth development; natural resources development; agriculture; as well as health and nutrition education 

and awareness. 

In fiscal year 2009, $3,321,000 was appropriated for the 1994 Institutions’ competitive extension grants. The 1994 Institutions’ ability to maintain existing programs and to respond to emerging issues such as food safety and homeland security, 

especially on border reservations, is severely limited without adequate funding. Increased funding is needed to support these vital programs designed to address the 

inadequate extension services that have been provided to Indian reservations by 

their respective state programs. It is important to note that the 1994 extension program does not duplicate the Federally Recognized Tribes Extension Program, formerly the Indian Reservation Extension Agent program. 1994 Tribal College Land 

Grant programs are very modestly funded. The 1994 Tribal College Land Grant Institutions have applied their ingenuity for making the most of every dollar they 

have at their disposal by leveraging funds to maximize their programs whenever 

possible. Some examples of 1994 extension programs include: Lac Courte Oreilles 

Ojibwa Community College in Wisconsin is strengthening the household economies 

of local reservation communities by offering financial education curriculum in managing budgets, saving for the future, and understanding the credit basics. Sitting 

Bull College, which serves reservation communities in both North and South Dakota, offers an equine extension program to help youth learn about the historical 

role of horses in American Indian Tribal life, while teaching them important leadership skills necessary to succeed in today’s world. These are just two examples of the 

innovative programs being conducted at 1994 Institutions. To continue and expand 

these successful programs, we request that the subcommittee support this competitive program by appropriating $5.0 million to sustain the growth and further success of these essential community-based extension programs. 

1994 Competitive Research Program.—As the 1994 Tribal College Land Grant Institutions enter into partnerships with 1862/1890 land grant institutions through 

collaborative research projects, impressive efforts to address economic development 

through natural resource management have emerged. The 1994 Research Program 

illustrates an ideal combination of Federal resources and tribal college-state institutional expertise, with the overall impact being far greater than the sum of its parts. 

We recognize the severe budget constraints under which Congress is currently functioning. However, the $1,610,000 appropriated in fiscal year 2009 is grossly inadequate to develop capacity and conduct necessary research at our institutions. The 

1994 Research Program is vital to ensuring that TCUs may finally be recognized 

as full partners in the Nation’s land grant system. Many of our institutions are currently conducting applied research, yet finding the resources to conduct this research to meet their communities’ needs is a continual challenge. This research authority opens the door to new funding opportunities to maintain and expand the research projects begun at the 1994 Institutions, but only if adequate funds are secured and sustained. A total research budget of $1,610,000, for which all 32 of the 

1994 Institutions compete for research dollars, is clearly insufficient. Priority issue 

areas currently being studied at the 1994 Institutions include: sustainable agriculture and forestry; biotechnology and bioprocessing; agribusiness management and 

marketing; plant propagation, including native plant preservation for medicinal and 

economic purposes; animal breeding; aquaculture; human nutrition (including 

health, obesity, and diabetes); and family, community, and rural development. The 

College of Menominee Nation in Wisconsin is collecting and analyzing data concerning forest health and sustainability that will help its tribal forest managers 

meet the growing demand for forest products while protecting the woodlands environment for future generations. Turtle Mountain Community College in North Dakota is studying the spread of West Nile virus, which causes serious diseases in animals and people. Results of the study will assist tribal efforts in the surveillance, 

prevention, and control of the mosquito-borne virus. These are just two examples 

of 1994 Research projects. We strongly urge the subcommittee to fund this program 

at a minimum of $3.0 million to enable our institutions to develop and strengthen 

their research capacity. 

1994 Institutions’ Educational Equity Grant Program.—This program is designed 

to assist 1994 Tribal College Land Grant Institutions with academic programs. 
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Through the modest appropriations first made available in fiscal year 2001, the 

TCU Land Grant Institutions have begun to support courses and to conduct planning activities specifically targeting the unique educational needs of their respective 

communities. 

The 1994 Institutions have developed and implemented courses and programs in 

natural resource management; environmental sciences; horticulture; forestry; and 

food science and nutrition. This last category is helping to address the epidemic 

rates of diabetes and cardiovascular disease that plague American Indian reservations. We request that the subcommittee appropriate a minimum of $3,342,000 to 

allow the 1994 Tribal College Land Grant Institutions to build upon their course 

offerings and successful activities that have been launched. 

Native American Endowment Fund.—Endowment installments that are paid into 

the 1994 Tribal College Land Grant Institutions’ account remain with the U.S. 

Treasury. Only the annual interest yield, less the USDA’s administrative fee, is distributed to the institutions. The latest gross annual interest yield for the 1994 Institutions Endowment was $3,929,412 and after the USDA takes its standard four-percent administrative fee, $3,772,236 should be available for distribution to the eligible 1994 Tribal College Land Grant Institutions by statutory formula. While the Department has not yet shared the breakdown of funds to be distributed to each of 

the 1994 Institutions for this year, last year the USDA administrative fee was larger than the amount paid to all but nine of the 1994 Tribal College Land Grant Institutions or in other words the USDA claims a fee that is higher than 70 percent of 

the 1994 Institutions’ payments. Once the distribution amounts are determined for 

this year’s disbursement, we fully expect similar results. 

Just as other land grant institutions historically received large grants of land or 

endowments in lieu of land, this endowment assists 1994 Tribal College Land Grant 

Institutions in establishing and strengthening their academic programs in such 

areas as curriculum development, faculty preparation, instruction delivery, and to 

help address critical facilities and infrastructure issues. Many of the colleges have 

used the endowment in conjunction with the Education Equity Grant funds to develop and implement their academic programs. As earlier stated, TCUs often serve 

as primary community centers and although conditions at some have improved substantially, many of the colleges still operate under less than satisfactory conditions. 

In fact, most of the TCUs continue to cite improved facilities as one of their highest 

priorities. Several of the colleges have indicated the need for immediate new construction and substantial renovations to replace buildings that have long exceeded 

their effective life spans and to upgrade existing facilities to address accessibility 

and safety concerns. 

Endowment payments increase the size of the corpus held by the U.S. Treasury 

and thereby increase the annual interest yield disbursed to the 1994 Tribal College 

Land Grant Institutions. These additional funds would continue to support faculty 

and staff positions and program needs within 1994 agriculture and natural resources departments, as well as to help address the critical and very expensive facilities needs at these institutions. Currently, the amount that each college receives 

from this endowment is not adequate to address both curriculum development and 

instruction delivery, and completely insufficient to address the necessary facilities 

and infrastructure projects at these institutions. In order for the 1994 Tribal College 

Land Grant Institutions to become full partners in this Nation’s great land grant 

system, we need and, through numerous treaty obligations, are due the facilities 

and infrastructure necessary to fully engage in education and research programs 

vital to the future health and well being of our reservation communities. We respectfully request the subcommittee fund the fiscal year 2010 endowment payment 

at $12.0 million—returning the payment amount to the pre across-the-board rescission level imposed each year on nondefense appropriated funding. We also request 

that the subcommittee review the USDA’s administrative fee and consider reducing 

it for the Native American Endowment so that more of these already limited funds 

can be utilized by the 1994 Tribal College Land Grant Institutions to conduct vital 

community based programs. 

Tribal College Essential Community Facilities Program (Rural Development).—In 

fiscal year 2009, $3,972,000 of the Rural Development Advancement Program 

(RCAP) funds appropriated for loans and grants to benefit federally recognized 

American Indian tribes was targeted for essential community facility grants at Tribal College Land Grant Institutions. This level of funding is a decrease of about half 

of a million dollars from fiscal year 2007, when the program was appropriated $4.5 

million—reduced to $4,419,000 by the across the board cut. We urge the subcommittee to designate $5.0 million each year of the next five fiscal years to afford 

the 1994 Institutions the means to aggressively address critical facilities needs, 

thereby allowing them to better serve their students and respective communities. 
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CONCLUSION

The 1994 Land Grant Institutions have proven to be efficient and effective vehicles for bringing educational opportunities to American Indians and the promise of 

self-sufficiency to some of this Nation’s poorest and most underserved regions. The 

modest federal investment in the 1994 Tribal College Land Grant Institutions has 

already paid great dividends in terms of increased employment, access to higher 

education, and economic development. Continuation of this investment makes sound 

moral and fiscal sense. American Indian reservation communities are second to none 

in their potential for benefiting from effective land grant programs and, as earlier 

stated, no institutions better exemplify the original intent of the land grant concept 

than the 1994 Land Grant Institutions. 

We appreciate your support of the 1994 Tribal College Land Grant Institutions 

and recognition of their role in the Nation’s land grant system. We ask you to renew 

your commitment to help move our students and communities toward self-sufficiency. We look forward to continuing our partnership with you, the U.S. Department of Agriculture, and the other members of the Nation’s great land grant system—a partnership with the potential to bring equitable educational, agricultural, 

and economic opportunities to Indian Country. 

Thank you for this opportunity to present our funding proposals to the subcommittee. We respectfully request your continued support and full consideration of 

our fiscal year 2010 appropriations recommendations. 

PREPARED STATEMENT OF THE AMERICAN PUBLIC POWER ASSOCIATION

The American Public Power Association (APPA) is the national service organization representing the interests of over 2,000 municipal and other state and locally 

owned utilities throughout the United States (all but Hawaii). Collectively, public 

power utilities deliver electricity to one of every seven electricity consumers (approximately 45 million people), serving some of the nation’s largest cities. However, 

the vast majority of APPA’s members serve communities with populations of 10,000 

people or less. 

We appreciate the opportunity to submit this statement outlining our fiscal year 

2010 funding priorities within the jurisdiction of the Agriculture, Rural Development, Food and Drug Administration and Related Agencies Subcommittee. 

Department of Agriculture: Rural Utility Service Rural Broadband Grants and 

Loans 

APPA was pleased with the funding level of $2.5 billion in the American Recovery 

and Reinvestment Act for ‘‘grants, loans and loan guarantees, for broadband infrastructure in any area of the United States.’’ APPA urges the Subcommittee to fully 

fund the Rural Utilities Service’s (RUS) rural grant and loan programs at or above 

the stimulus levels. 

APPA believes it is important to provide incentives for the deployment of 

broadband to rural communities, many of which lack broadband service. Increasingly, access to advanced communications services is considered vital to a community’s economic and educational development. In addition, the availability of 

broadband service enables rural communities to provide advanced health care 

through telemedicine and to promote regional competitiveness and other benefits 

that contribute to a high quality of life. Approximately one-fourth of APPA’s members are currently providing broadband service in their communities. Several APPA 

members are planning to apply for RUS broadband loans to help them finance their 

broadband projects. 

Department of Agriculture: Title IX Programs 

APPA supports full funding of programs authorized in Title IX of the 2008 Farm 

Bill for energy efficiency, renewable energy and biofuels. APPA requests the full fiscal year 2010 funding level of $60 million for the Rural Energy for America Program 

(REAP), $5 million for the Rural Energy Self-Sufficiency program, and $5 million 

for the Community Wood Energy Program. 

PREPARED STATEMENT OF THE AMERICAN SOCIETY FOR MICROBIOLOGY

The American Society for Microbiology (ASM) is pleased to submit the following 

testimony on the fiscal year 2010 appropriation for the Food and Drug Administration (FDA) research and regulatory programs. The ASM is the largest single life 

science organization in the world with about 42,000 members. The ASM mission is 
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to enhance the science of microbiology, to gain a better understanding of life processes, and to promote the application of this knowledge for improved health and environmental well-being. The ASM recommends an appropriation of $2.25 billion for 

the FDA in fiscal year 2010, a $386 million increase over the fiscal year 2009 budget. 

The FDA is responsible for the evaluation of domestic and foreign foods and consumer products to protect the public health and safety. Funding levels for sometime 

have significantly fallen below amounts needed to enable the FDA to fulfill its growing oversight for nearly one-quarter of the U.S. Gross National Product. The ASM 

appreciates the estimated $1 billion for food safety anticipated in the President’s 

proposed fiscal year 2010 budget. However, serious budget shortfalls in the past 

have diluted FDA’s ability to respond to escalating, often unmet demands on its personnel and resources not only in food safety, but also across the agency. Each year, 

the Nation spends nearly $1.5 trillion on FDA regulated goods. It is essential that 

FDA have state-of-the-art scientific capabilities and a fully staffed contingent of scientists if the United States is to maintain its economic competitiveness. FDA’s mission is not only to ensure product safety but to also stimulate and facilitate innovation. 

Since January, the FDA has approved new drugs for diabetes and malaria, a 

rapid diagnostic test to detect the avian influenza H5N1 virus in minutes rather 

than hours, and the first approved drug made with materials from genetically engineered animals. Threats to public health persist, including sporadic food borne illnesses linked to everyday foods like tomatoes, peanuts, and recently, alfalfa sprouts. 

FDA’s regulatory responsibilities cover the bulk of U.S. domestic and imported 

foods, plus medical devices, drugs, food additives, blood and vaccine products, and 

cosmetics. Since 2001, its mission has also expanded to counterterrorism and homeland security. Several external reviews of FDA performance have confirmed in recent years that inadequate funding for the agency has undermined efforts to protect 

public health in the United States. 

A SAFE AND SECURE U.S. FOOD SUPPLY DEPENDS ON FDA EXCELLENCE

Regulating food in the United States is an enormous task. Food expenditures exceed $1.1 trillion annually. In the past 5 years, the volume of imported products has 

doubled, with 60 percent categorized as food or food-related products, and is predicted to triple by 2015. Yet the FDA examined less than 1 percent of the 7.6 million 

fresh produce lines imported from fiscal years 2002 to 2007. This year, the Nation 

will import agricultural products worth an estimated $81 billion, continuing the 

steady trend of rising U.S. consumption of imported food. The number of identified 

food borne disease outbreaks has tripled since the early 1990s. Each year, about 76 

million people contract a food borne illness in the United States, about 325,000 require hospitalization, and about 5,000 die. The U.S. Department of Agriculture 

(USDA) estimates medical costs and lost wages associated with just five of the 

major food borne illnesses reach $6.9 billion annually, and total costs are likely 

much higher. The Centers for Disease Control and Prevention (CDC) has enumerated more than 250 different food borne diseases and more causative agents continue to be found. FDA actions thus far this year have included the current recall 

of Salmonella-contaminated pistachio products; a consumer warning about certain 

cheeses that could contain Listeria monocytogenes, bacteria that can cause serious 

and sometimes fatal infections; and advisories to food preparers about possible 

norovirus in some domestic oysters. 

As food moves from farm to table it encounters innumerable points for possible 

contamination, either accidental or deliberate. To mitigate failures in our highly 

complex food supply, the FDA’s ongoing Protecting America’s Food Supply initiative 

integrates food safety and food defense. In November 2007, the FDA launched its 

Food Protection Plan with a three-pronged strategy of expanded prevention, improved intervention, and more rapid response to events like disease outbreaks. The 

FDA also participates in the multiagency Action Plan for Import Safety, publishing 

in March its final rule on required prior notice of foreign food shipments arriving 

at U.S. ports. Unfortunately, these and other FDA food safety programs have been 

consistently underfunded to the detriment of public health. 

The following are examples of FDA’s enormous responsibilities: 

—The FDA regulates about 80 percent of the U.S. food supply, responsible for 

$417 billion worth of domestic food and $49 billion in imported food annually. 

—In the United States, the agency oversees more than 136,000 registered domestic food facilities (over 44,000 food manufacturers and processors, plus roughly 

113,000 warehouses that include storage tanks and grain elevators). 
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—FDA personnel collaborate with staff at other Federal agencies and State and 

local authorities to regulate more than 2 million farms, 935,000 restaurants and 

institutional food facilities, and 114,000 supermarkets, grocery stores, and other 

food outlets. 

—Over 300 U.S. ports receive products from more than 150 countries/territories. 

In the last decade, the number of food entry lines has tripled, shipped from approximately 200,000 FDA registered foreign facilities that manufacture, process, 

pack, or store food consumed in the United States. 

In 2008, the CDC concluded that the incidence of the most common food borne 

illnesses had changed very little in the previous 3 years, a grim plateau in preventing diseases caused by Salmonella, Escherichia coli and other food borne pathogens. The disturbing report joined other official reports, expert committee reviews, 

and publicized disease investigations that abundantly demonstrate the importance 

of improving food safety in the United States. In November 2007, FDA’s own 

Science Advisory Board published a highly critical report concerning the state of 

science at FDA and the ability to undertake its massive mission. Last September, 

the Government Accounting Office (GAO) published its negative review of the FDA’s 

oversight of domestic and imported fresh produce, citing funding shortages and too 

few FDA inspectors as contributing factors. 

Nationwide outbreaks of food-related illness grab headlines, exact high costs for 

the food industry, and force health officials to scramble to conduct the scientific detective work and implement preventive strategies to contain the problem. These outbreaks absorb significant FDA resources and personnel, like the far-reaching fallout 

from Salmonella-contaminated peanut products that is still rippling through the 

U.S. food industry. Health officials have reported more than 600 cases of disease 

tied to consumption of the suspect products, leading to the voluntary recall of more 

than 2,100 products in 17 categories by more than 200 companies, and the list continues to grow. In January, the FDA expanded the recall list to include pet food 

products that contain peanut paste made by the company, which has declared bankruptcy. The large number of products and brands, magnified by the large quantities 

of some products, makes this one of the most complex food recalls in U.S. history. 

FDA OVERSIGHT OF DRUGS, VACCINES, AND DIAGNOSTICS PROTECTS U.S. CONSUMERS

Just as FDA’s responsibilities in food safety have increased enormously over the 

past decade, so has its responsibility in other areas, especially drug safety, including 

adverse events as well as contamination both from microbial and chemical sources. 

We share the concerns detailed in the 2006 Report on Drug Safety and the Science 

Board Report. 

The steady release of new therapeutic drugs, vaccines, and diagnostic tests by the 

U.S. private sector helps protect the Nation from infectious and other types of diseases. Several divisions within the FDA focus on evaluating both new and on-themarket products, assuring product safety and efficacy on behalf of health care providers, their patients, and the general public. Limited FDA budgets in recent years 

have not fully met the massive volume of responsibilities involved in this wide-ranging oversight, which includes detailed science-based lab analyses of new and established products, data assessment of incident reports, guidance statements and product alerts to the public and to health care providers, recall of unsafe products, and 

more. 

Recent shortages of vaccines commonly used against rabies and Haemophilus influenza type b (Hib) have underscored the importance of FDA-approved vaccines 

regulated by the agency’s Center for Biologics Evaluation and Research (CBER). Before development of Hib conjugate vaccines, about 20,000 U.S. children had Hib infections each year, including 12,000 cases of bacterial meningitis of which about 5 

percent died. Since the Nation’s Hib immunization program began in the early 

1990s, incidence has decreased 99 percent. In developing countries, Hib remains a 

major cause of respiratory infections in infants and children. Unfortunately, a voluntary recall of Hib vaccine by a U.S. manufacturer in December 2007 resulted in 

shortages that have since been implicated in small Hib outbreaks in Minnesota and 

Pennsylvania. In June 2008, a French supplier of rabies vaccine temporarily halted 

production to upgrade its facilities, prompting U.S. officials to issue alerts regarding 

priority use of limited vaccine supplies. To maintain adequate immunization coverage, the FDA not only monitors already approved vaccines, but also evaluates the 

latest vaccine technologies. This March, the agency approved a vaccine to prevent 

Japanese encephalitis (JE) that was developed using cell culture technology, making 

it the only JE vaccine available in the United States. Found mainly in Asia, the 

viral disease affects about 30,000 to 50,000 people each year, resulting in 10,000 to 
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15,000 deaths. It is rarely seen in the United States, but there have been cases 

among those traveling to Asia. 

FDA scientists who evaluate new products must be able to assess leading-edge 

product development methodologies. For example, CBER researchers just completed 

a ‘‘proof-of-concept’’ study of a test using nanotechnology to detect quickly the smallest amount of anthrax toxin. Based on research at the Center for Devices and Radiological Health (CDRH), the FDA approved in March the first DNA test that identifies the two types of human papillomavirus (HPV) responsible for the majority of 

cervical cancers among U.S. women. HPV is the most common sexually transmitted 

infection in the United States, causing more than 6 million new cases each year. 

The Center for Drug Evaluation and Research (CDER) assures that all prescription 

and over-the-counter drugs are safe and effective, overseeing a regulatory portfolio 

of many thousands of products. In 2007 alone, CDER approved nearly 80 drugs and 

biologics, a laborious process that demands singular scientific capabilities. 

The FDA also plays a key role in addressing the issue of antimicrobial resistance 

through its initiatives on monitoring and surveillance of antimicrobial resistance, facilitating the appropriate use of products and tests for infectious diseases, educating 

the public and health professionals about safe and effective use of antimicrobials, 

and assuring accurate product labeling. 

SCIENCE AT FDA NEEDS MORE RESOURCES, TRAINED PERSONNEL

The ASM is very concerned about the perceived weaknesses in FDA science and 

the possible negative impacts on the Nation’s health. The 2007 Science Board report 

conducted a thorough external review of science and technology across the agency. 

It identified several problem areas within the agency where FDA science was not 

keeping pace with the private sector, for example, the expertise necessary to evaluate products related to nanotechnology, robotics, systems biology, and especially 

genomics. The report also indicted inadequate computing capabilities used for surveillance and incident reporting, and a dwindling workforce of those trained in 

science-based investigation and research. In the 2008 GAO report on FDA’s oversight of fresh produce, the agency acknowledged that it lacks resources for funding 

crucial extramural or internal research to understand produce contamination by 

pathogens such as E. coli O157:H7 or Salmonella. The FDA remains the Nation’s 

foremost regulatory agency, but optimal oversight of increasingly complex products 

and systems requires fully equipped FDA laboratories with leading-edge capabilities. This is of particular concern with regard to tissue based products and screening 

for adventitious infectious agents. 

Research programs within the FDA focus on supporting the agency’s regulatory 

role with the necessary science and technology tools. Understanding the latest advances in multiple scientific disciplines is essential for FDA regulators, evidenced 

by the agency’s conclusion last year that meat and milk from clones of cattle, swine 

and goats are safe to eat, based on years of FDA study and analysis. The Center 

for Food Safety and Applied Nutrition (CFSAN) conducts food, cosmetic, and color 

additive safety research to protect the public from illnesses, contaminants, or other 

threats from consumer goods. Its scientists study the emergence or re-emergence of 

food borne microbial pathogens and evaluate or develop new lab methods needed to 

investigate outbreaks. The Office of Regulatory Affairs (ORA) also funds research 

activities to inform policy and regulation, plus contributing to the Nation’s food defense efforts. ORA-supported research includes validation of detection methods for 

potential bioterrorism agents like Clostridium botulinum neurotoxin. The FDA has 

identified critical areas of needed research that include rapid test kit development, 

confirmatory methods, virology, biotechnology, in-vitro testing, and laboratory enhancement. To remedy these technological gaps, increased funding for FDA research 

is needed. As detailed in the 2007 Science Board Report, the continued underfunding of the Critical Path Initiative to bring FDA science into the 21st Century 

is a particular problem. 

Last year, additional funding in the fiscal year 2009 budget did add more than 

1,300 new skilled employees. The second hiring phase, with a target of 1,400 additional staff, is underway, including chemists, microbiologists, and medical officers. 

However, critical personnel needs still remain, especially in the filed of genomics, 

information technology, and risk communication. The agency also leverages resources through partnering with other stakeholders, for example, the National Center for Food Safety and Technology, a research consortium whose members investigate new molecular tools to study antimicrobial resistance among pathogens and 

other emerging food safety issues. In September, the FDA awarded $5.2 million in 

grants to various State and local agencies to enhance food and feed safety including 

the first Rapid Response Team cooperative agreements with six U.S. States to cre-
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ate RRT teams able to respond to all food hazard incidents in the farm-to-table continuum. Also included were grants to upgrade chemistry labs to better analyze food 

samples collected by the FDA or other agencies, part of the ongoing effort to boost 

the surge capacity of State health department laboratories. However, this level of 

research funding is woefully inadequate given the cost of this type of research and 

the unfunded research priorities across the agency. 

ASM RECOMMENDS A SUBSTANTIAL INCREASE IN FDA FUNDING

The ASM urges Congress to support the irreplaceable role of the Food and Drug 

Administration in protecting public health and safety. Repeated cautionary reports 

have warned of besieged and deteriorating FDA capabilities in the face of soaring 

imports, new product lines, and issues about drug safety. The ASM recommends 

$2.25 billion for the FDA appropriation in fiscal year 2010. 

PREPARED STATEMENT OF THE AMERICAN SOCIETY FOR MICROBIOLOGY

The American Society for Microbiology (ASM) is pleased to submit the following 

testimony on the fiscal year 2010 appropriation for the U.S. Department of Agriculture (USDA) research and education programs. The ASM is the largest single life 

science organization in the world with more than 40,000 members. The ASM mission is to enhance the science of microbiology, to gain a better understanding of life 

processes, and to promote the application of this knowledge for improved health and 

environmental well-being. 

The science based missions of the USDA, fueled by its research and education programs, are essential to human, environmental and animal health. The ASM strongly 

urges Congress to appropriate at least $1.24 billion for the Agriculture Research 

Service in fiscal year 2010, $1.24 billion for the Cooperative State Research, Education and Extension Service, and to provide $300 million for the Agriculture and 

Food Research Initiative (AFRI). Agriculture research plays an important role in the 

improvement of food safety, the environment, and animal and plant health but also 

contributes to the economic well-being of the nation. In a September 2007 report entitled: ‘‘Economic Returns to Public Agriculture Research,’’ the USDA Economic Research Service (ERS) found that the average rate of return from public investment 

in agriculture research is an impressive 45 percent on the dollar. In reviewing more 

than thirty-five economic studies on the social rate of return, the ERS also found 

that such a high rate of return is shared by all levels of the agricultural continuum, 

from the producer to the consumer. 

THE AGRICULTURE RESEARCH SERVICE (ARS)

The core research arm of the USDA, the ARS is divided into four National Programs that focus on critically important areas of agricultural research: 

—Nutrition, Food Safety/Quality 

—Animal Production and Protection 

—Natural Resources and Sustainable Agricultural Systems 

—Crop Production and Protection 

Agricultural research is critically important to human and animal health. The 

ARS has funded a number of cooperative research projects related to zoonotic viruses including a study evaluating influenza vaccines in pigs and the establishment 

of a pig model from the 1930 H1N1 swine influenza. The ARS works to understand 

the biology of animal pathogens including the H1N1 swine virus to combat such outbreaks at the animal level and reduce the risk to humans. The USDA’s Animal and 

Plant Health Inspection Service (APHIS) also works extensively with zoonotic virus 

monitoring which contributes to the knowledge base of the ARS. 

The ASM urges Congress to fund the ARS with $1.24 billion in fiscal year 2010, 

a 4 percent increase from the fiscal year 2008 level. 

Food Safety 

The ASM supports the Administration’s pledge to increase funding for food safety. 

The first step to ensuring a safe and plentiful national food source is to maintain 

a successful research platform. 

Despite advances, food safety remains a serious and complex issue. Recent outbreaks of Salmonella Saintpaul demonstrate how quickly and severely pathogens 

can spread through the population. Understanding the cause of foodborne illness is 

an important step towards a better understanding of the ways to treat and prevent 

future outbreaks. According to the CDC, in the United States there are an estimated 76 million cases of foodborne illness each year, resulting in 325,000 hospitalizations and 5,000 deaths. Agricultural research is an irreplaceable tool in the 
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fight against foodborne illness as researchers supported by the USDA work to understand and prevent the transference of some types of bacteria from the food supply. 

Recently, the CDC’s Morbidity and Mortality Weekly Report stated that: ‘‘None 

of the Healthy People 2010 targets for reduction of foodborne pathogens were 

reached in 2008. The lack of recent progress points to gaps in the current food safety 

system and the need to continue to develop and evaluate food safety practices as 

food moves from the farm to the table.’’ Increased funding for the ARS is critical 

to the prevention, treatment and understanding of foodborne illness, both current 

and future outbreaks. 

Antimicrobial Resistance 

The prevalence of antimicrobial resistance remains a threat to human and animal 

health as foodborne and other bacterial pathogens are increasingly changing and 

evolving to adapt to new antimicrobial agents. The USDA has supported a number 

of important research projects that bring together basic and applied research to 

combat this very real threat. Adequate funding for the USDA is vital to ensure such 

research continues as the occurrence of antimicrobial resistance increases. 

Climate Change 

The ARS supports projects that work to ensure the effects of global change on agriculture are understood and ways to mitigate risks are developed. The impact of 

global climate change and global warming trends on agricultural yields could be severe. Without adequate funding for the ARS, the impact of climate change on food 

production and plant health could be neglected, with disastrous results. Current research projects related to climate change include: 

—Crop and Weed Responses to Increasing Atmospheric Carbon Dioxide 

—Evaluating Effects of Nitrogen Deposition and Ambient Ozone on an Invasive 

Plant in the National Capitol Region 

—Soil Carbon in Urban Environments 

The ARS’s Global Change National Program conducted a 5 year cycle of study 

from 2002—2007 to explore the effects of Global Change in depth. The programs’ 

accomplishment report, conducted by non-ARS scientists, released in 2008 stated: 

‘‘The ARS is poised as a leader in the field of global change research to help understand the impacts of global change on agriculture, enable agriculture to adapt to 

global change and reduce the impact of agriculture on factors affecting global 

change.’’ The report also emphasized the need for continued and future research to 

combat the evolving and complex problems that arise with climate change. Continued and sustainable funding for the ARS will help to ensure that other such crucial 

research can be completed to further the understanding of climate change. 

Cooperative State Research, Education and Extension Service (CSREES) 

Soon to become the National Institute of Food and Agriculture (NIFA), CSREES 

works with land-grant universities, public and private organizations and supports 

research that increases understanding and knowledge of the unique link between 

the environment, agriculture and human health. Supporting research at the local 

and state level allows the CSREES to fund programs that impact not only scientific 

research, but local economies as well. The ASM urges Congress to appropriate at 

least $1.24 billion for the CSREES in fiscal year 2010, a 4 percent increase from 

the fiscal year 2008 level. 

CSREES supports a number of important areas of interest categorized as National 

Emphasis Areas: 

—Agricultural Systems 

—Animals 

—Biotechnology & Genomics 

—Economics & Community Development 

—Education 

—Families, Youth & Communities 

—Food, Nutrition & Health 

—International 

—Natural Resources & Environment 

—Pest Management 

—Plants 

—Technology & Engineering 

Climate Change 

The effects of climate change are almost guaranteed to impact all life forms, and 

the research funded by the CSREES works to ensure that the best science is presented to offset such impacts. Supporting universities as well as public and private 
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organizations lends opportunity for the best science and research to become a part 

of the larger solution. 

The buildup of CO2 in the atmosphere has caused considerable concern as the 

negative effects of climate change are studied and understood. The Consortium for 

Agricultural Soils Mitigation of Greenhouse Gases, funded by the CSREES, is working to develop the technologies and strategies to successfully implement soil carbon 

sequestration and greenhouse gas reduction programs. Such initiatives are at the 

forefront of the race to find ways to combat the negative effects of global climate 

change. The CSREES support of such successful programs sends the message that 

climate change is an issue that needs collaboration from all science concentrations, 

especially from agricultural research. 

Biofuels 

Proven to be the most resourceful and sustainable alternative to fossil fuels, 

biofuels bring the promise of a cleaner and more efficient source of energy. Much 

like fossil fuels however, biofuels create a substantial amount of waste called Glycerin that is difficult to break down. The creation of waste has slowed the implementation of biofuels as a mainstream, alternative to traditional fossil fuels. A project 

funded by the CSREES however, has developed a fermentation technology that combines E. coli with glycerin to create a high value chemical reducing the existence 

of waste, as the chemical created can be used as a commodity on the domestic market. Such projects, as supported by the CSREES, are providing real-life solutions to 

problems once considered too daunting to tackle. 

The Agriculture and Food Research Initiative (AFRI) 

AFRI was established in the Food, Conservation, and Energy Act of 2008 as a 

competitive grants program aimed to support research, education and the extension 

of our nation’s food and agricultural systems. Formerly operating as the National 

Research Initiative program (NRI), AFRI is the foundation of competitive grants 

within the USDA, supporting a focus on six core areas within the food and agricultural sciences: 

—Plant Heath and Production 

—Animal Health 

—Food Safety, Nutrition and Health 

—Renewable Energy, Natural Resources and Environment 

—Agriculture Systems and technology 

—Agriculture Economics and Rural Communities 

AFRI moves the work of scientists past research and into development, implementation, education, and extension. Investments by the NRI in this type of research 

have resulted in a number of advances in critical issue areas such as, food safety, 

food security, sustainable fuel production and ecosystem health services. The importance of these programs on the overall health of the Nation cannot be underestimated. AFRI supports essential research with far reaching impacts into human, environmental and plant health, the basis of life. 

Currently authorized at $700 million per year, the ASM strongly urges Congress 

to fund AFRI with at least $300 million for fiscal year 2010. 

Education and Workforce 

Investing in research at the USDA ensures that coming generations of researchers, educators and students have the opportunity to stay within the agricultural 

sciences and keep the Nation competitive on a global scale. Reduced or stagnant 

funding sends the detrimental message to the Nation’s students and research scientists that agricultural and biological research is not a worthwhile field to pursue. 

This risks a very real and problematic ‘‘brain drain’’ compromising the status of the 

United States as a world leader in cutting edge scientific research. Ensuring funding for competitive grants programs and basic research will help to send the positive 

message that investing in agricultural and biological sciences is worthwhile. 

Conclusion 

The ASM urges Congress to increase research and education funding in the USDA 

budget, and provide at least $1.24 billion for the ARS, $1.24 billion for the Cooperative State Research, Education and Extension Service, and $300 million for AFRI 

in fiscal year 2010. Research in the agricultural and biological sciences is imperative 

to combat current and future threats to human, environmental, plant and animal 

health. The research supported by the USDA should be a priority that deserves 

steady, predictable and sustainable funding by the Federal Government. The future 

of our agricultural systems, a basis for human health, relies on it. 
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1Of the six HNRCs, three are fully administered by ARS and are located in Davis, CA, Beltsville, MD, and Grand Forks, ND. The other three are administered through cooperative agreements with Baylor University Medical Center in Houston, TX; Tufts University in Boston, MA; 

and, the University of Arkansas in Little Rock. 

The ASM appreciates the opportunity to provide written testimony and would be 

pleased to assist the Subcommittee as it considers the fiscal year 2010 appropriation 

for the USDA. 

PREPARED STATEMENT OF THE AMERICAN SOCIETY FOR NUTRITION (ASN) 

The American Society for Nutrition (ASN) appreciates this opportunity to submit 

testimony regarding fiscal year 2010 appropriations for the U.S. Department of Agriculture (USDA) and specifically, its research programs. ASN is the professional 

scientific society dedicated to bringing together the world’s top researchers, clinical 

nutritionists and industry to advance our knowledge and application of nutrition to 

promote human and animal health. Our focus ranges from the most critical details 

of research to very broad societal applications. ASN respectfully requests $1.377 billion for ARS, with $120 million of the total allocated to the Human Nutrition Research program. We request $300 million for the Agriculture and Food Research Initiative in fiscal year 2010. 

Basic and applied research on nutrition, food production, nutrient composition, 

food processing and nutrition monitoring is critical to American health and the U.S. 

economy. Awareness of the growing epidemic of obesity and the contribution of 

chronic illness to burgeoning health care costs has highlighted the need for improved information on dietary intake and improved strategies for dietary change. 

Demand for a safer and more nutritious food supply continues to increase. Preventable chronic diseases related to diet and physical activity cost the economy over 

$117 billion annually, and this cost is predicted to rise to $1.7 trillion in the next 

10 years. Nevertheless, funding for food and nutrition research at USDA has not 

increased in real dollars since 1983! This decline in our national investment in agricultural research seriously threatens our ability to sustain the vitality of food, nutrition and agricultural research programs and in turn, threatens the future of our 

economy and the health of our Nation. 

USDA historically has been identified as the lead nutrition agency and the most 

important Federal agency influencing U.S. dietary patterns. Through the nutrition 

and food assistance programs, which form roughly 60 percent of its budget, USDA 

has a direct influence on the dietary intake (and ultimately the health) of millions 

of Americans. It is important to better understand the impact of these programs on 

the food choices, dietary intake, and nutritional status of those vulnerable populations which they serve. Research is the key to achieving this understanding, and 

it is the foundation upon which U.S. nutrition policy is built. 

USDA is in full or in part responsible for the development and translation of Federal dietary guidance, implementation of nutrition and food assistance programs 

and nutrition education; and, national nutrition monitoring. The USDA Human Nutrition Research programs ensure nutrition policies are evidence-based, ensure we 

have accurate and valid research methods and databases, and promote new understanding of nutritional needs for optimal health. 

ARS Human Nutrition Research Program 

USDA has built a program of human nutrition research, housed in six centers 

(HNRCs) 1 geographically disperse across the Nation and affiliated with the ARS, 

which links producer and consumer interests and forms the core of our knowledge 

about food and nutrition. These unique centers are working closely with a wide variety of stakeholders to determine just how specific foods, food components, and physical activity can act together during specific life-stages (e.g. prior to conception, in 

childhood, in older adult years) to promote health and prevent disease. The HNRCs 

are a critical link between basic food production and processing and health, including food safety issues. The center structure adds value by fully integrating a multitude of nutritional science disciplines that cross both traditional university department boundaries and the functional compartmentalization of conventional funding 

mechanisms. 

An important basic premise of research in the HNRCs is that many chronic diseases, such as diabetes and obesity, can be prevented by lifestyle issues, the most 

important of which are: consuming appropriate amounts of a well-balanced, healthful diet; and regularly engaging in adequate levels of physical activity. Using stateof-the-art facilities and a concentration of critical scientific teams, the HNRCs are 

conducting the highest quality translational research. Also of importance are the 
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long-term experiments involving the derivation of dietary reference intake values 

and nutrient requirements of individuals. Often compared to the intramural program at the National Institutes for Health, these centers tackle projects that are 

unlikely to be funded through other means, such as through competitive grants or 

by industry. 

The flat-funding of ARS in fiscal year 2009, coupled with flat-funding of the 

Human Nutrition Research program for over 6 years, seriously jeopardizes the future of the centers, their important research projects, and the critical infrastructure 

provided by the USDA from which the HNRCs and scientists benefit. An estimated 

$10 million in additional funds is needed across the six HNRCs to ensure they can 

continue current research projects and to restore purchasing power lost to inflation 

over years of flat budgets. 

Another example of the unique nutrition research at ARS is the nutrition monitoring program, ‘‘What We Eat in America’’ (WWEIA). This program allows us to 

know not only what foods Americans are eating, but also how their diets directly 

affect their health. Information from the survey guides policies on food safety, food 

labeling, food assistance, military rations, pesticide exposure and dietary guidance. 

In addition to having an impact on billions of dollars in Federal expenditures, the 

survey data leverages billions of private sector dollars allocated to nutrition labeling, food product development and production. Despite this, WWEIA has been flatfunded at $11.5 million for over 13 years. The USDA budget for WWEIA must be 

increased two-fold to $23 million. Otherwise, we risk losing this national treasure 

if we do not restore lost funding and strengthen it for the future. 

Agriculture and Food Research Initiative Competitive Grants Program 

The Food, Conservation, and Energy Act of 2008 established the Agriculture and 

Food Research Initiative (AFRI), a new competitive grants program authorized at 

$700 million annually, for research, extension, and education in support of our nation’s food and agricultural systems within the soon-to-be-established National Institute of Food and Agriculture at USDA. This unique program, the successor to 

USDA’s National Research Initiative (NRI) and the Initiative for Future Agriculture 

and Food Systems (IFAFS), takes research and innovation beyond the development 

phase, into implementation through contemporary education and extension programs. 

AFRI now includes programs aimed to improve the Nation’s nutrition and health 

which were previously funded by other mechanisms. The nutrition- and health-related research focuses on two objectives: (1) improving human health by better understanding an individual’s nutrient requirements and the nutritional value of 

foods; and (2) promoting research on healthier food choices and lifestyles. For example, USDA-funded projects funded by the Human Nutrition and Obesity program 

have led to a better understanding of the behavioral and environmental factors that 

influence obesity, and to the development and evaluation of effective interventions. 

Specifically, USDA competitive grants have funded nutrition education interventions focusing on the reduction of childhood obesity in low-income families. 

While ASN believes the program should be funded at its full authorization level 

of $700 million, we understand that in the current fiscal climate, that is unlikely. 

However, with the Nation and world facing unprecedented health, food security and 

nutrition challenges, now is the time to renew investment in our Nation’s agricultural research enterprise. A strong commitment to AFRI of $300 million in fiscal 

year 2010 (exclusive of any funding identified for the former Section 406 programs), 

with a goal of $500 million in total funding by fiscal year 2015, will provide America’s agriculture, food and nutrition scientists, land managers and farmers with the 

tools necessary to solve problems and keep the country competitive, while also protecting the natural resource base and environment, enhancing human nutrition and 

fostering vibrant rural communities. 

The AFRI and the Human Nutrition Research Program under ARS are symbiotic 

programs that provide the infrastructure and generation of new knowledge that 

allow for rapid progress towards meeting national dietary needs. These programs 

allow USDA to make the connection between what we grow and what we eat. And 

through strategic nutrition monitoring, we learn more about how dietary intake affects our health. 

ASN thanks your Committee for its support of the ARS and the AFRI Competitive 

Grants Program. If we can provide any additional information, please contact Mary 

Lee Watts, ASN Director of Science and Public Affairs, at (301) 634–7112 or 

mwatts@nutrition.org. 
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PREPARED STATEMENT OF THE AMERICAN SOCIETY OF PLANT BIOLOGISTS

On behalf of the American Society of Plant Biologists (ASPB) we submit this 

statement for the official record in support of increased funding for the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture, specifically funding the Agriculture and Food Research Initiative at $300 million. This testimony highlights the importance of biology, particularly plant biology, as the Nation seeks to address vital issues including a sustainable food supply, climate 

change and energy security. We would like to thank the Subcommittee for its consideration of this testimony. 

The American Society of Plant Biologists is an organization of more than 5,000 

professional plant biologists, educators, graduate students, and postdoctoral scientists. A strong voice for the global plant science community, our mission—which 

is achieved through engagement in the research, education, and public policy 

realms—is to promote the growth and development of plant biology and plant biologists and to foster and communicate research in plant biology. The Society publishes 

the highly cited and respected journals Plant Physiology and The Plant Cell, and 

it has produced and supported a range of materials intended to demonstrate fundamental biological principles that can be easily and inexpensively taught in school 

and university classrooms by using plants. 

FOOD, FUEL, CLIMATE CHANGE, AND HEALTH: PLANT BIOLOGY RESEARCH AND

AMERICA’S FUTURE

Plants are vital to our very existence. They harvest sunlight, converting it to 

chemical energy for food and feed; they take up carbon dioxide and produce oxygen; 

and they are almost always the primary producers in the Earth’s ecosystems. Indeed, basic plant biology research is making many fundamental contributions in the 

areas of fuel security and environmental stewardship; the continued and sustainable 

development of better foods, fabrics, and building materials; and in the understanding of basic biological principles that underpin improvements in the health and 

nutrition of all Americans. To go further, plant biology research can help the Nation 

both predict and prepare for the impacts of climate change on American agriculture, 

and it can make major contributions to our Nation’s efforts to combat global warming. 

In particular, plant biology is at the center of numerous scientific breakthroughs 

in the increasingly interdisciplinary world of alternative energy research. For example, interfaces among plant biology, engineering, chemistry, and physics represent 

critical frontiers in both basic biofuels research and bioenergy production. Similarly, 

with the increase in plant genome sequencing and functional genomics, the interface 

of plant biology and computer science is essential to our understanding of complex 

biological systems ranging from single cells to entire ecosystems. 

Plant biology also has much to offer to our basic understanding of biology. Many 

common biological problems can best be addressed using plants. For example, plants 

cells are totipotent and, unlike animal cells, can be regenerated to whole plants. 

Many genetic studies are best done in plants due to the ability to analyze large 

numbers of individuals. Fundamental biological discoveries (e.g., the discovery of 

gene silencing) derive from initial studies in plants. 

Despite the fact that plant biology research—the kind of research funded by 

USDA—underpins so many vital practical considerations for our country, the 

amount invested in understanding the basic function and mechanisms of plants is 

relatively small when compared with the impact it has on multibillion dollar sectors 

of the economy like energy, agriculture, health and nutrition. 

RECOMMENDATIONS

ASPB, as a spokesperson for the plant science community, is in an excellent position to articulate the Nation’s plant science priorities as they relate to agriculture. 

Our recommendations, in no particular order, are as follows: 

—With the new Farm Bill and a new research structure, it is ASPB’s hope that 

USDA will have an elevated role to play as part of the expanding Federal research landscape. USDA already funds research that is intended to provide a 

foundation for creating sustainable food and new energy supplies; however, 

much higher investment in competitive funding is needed if the Nation is to 

continue to make ground-breaking discoveries. ASPB strongly encourages the 

appropriation of at least $300 million in fiscal year 2010 for the Agriculture and 

Food Research Initiative (AFRI). ASPB encourages the full funding of $700 million to AFRI within 5 years. AFRI, authorized at $700 million, will play a vital 
136 

role in maintaining America’s food and energy security through funding innovative research. 

—Climate change is real and will have significant impacts on agriculture and our 

way of life for the foreseeable future. There are significant questions that must 

be answered as to how climate change will impact food production and the environment. There are also clear opportunities to use biological systems to ameliorate and respond to climate change, such as through carbon sequestration or 

modification of plants to resist environmental stress. Therefore, ASPB calls for 

additional funding focused on studies of the effect of climate change on agricultural cropping systems, basic studies of its effects on plant growth and development, and targeted research focused on modification of plants to resist climate 

change and for use in carbon sequestration. 

—Current estimates predict a significant shortfall in the needed scientific and engineering workforce as the demographics of the U.S. workforce changes. For example, there is a clear need for additional scientists in the area of energy research and, also, plant breeding. USDA has not traditionally been a major funding agency for education and training, other than that which occurs through the 

funding of individual investigator and center grants. Given the expected need 

for additional scientists and engineers who are well-grounded in agriculture research and development activities, ASPB calls for funding of specific programs 

(e.g., training grants) that are targeted to provide this needed workforce over 

the next 10 years and to adequately prepare these individuals for careers in the 

agricultural research of the future. 

—Considerable research interest is now being paid to the use of plant biomass for 

energy production. Progress in this area has been strongly affected by the ‘‘fuel 

vs. food’’ debate, which arose from the current emphasis on the use of corn for 

ethanol production. A response to this debate has been to switch the focus to 

plant species that can be grown exclusively for biomass (e.g., switchgrass, 

miscanthus, etc). However, if these crops are to be used to their full potential, 

considerable effort must be expended to improve our understanding of their 

basic biology and development, as well as their agronomic performance. These 

novel crops have not benefitted from many years of improvements in crop management and breeding that have been bestowed upon our current major crops 

(e.g., soybean, corn)—improvements that, among other things, have vastly increased yield and agronomic efficiency. Although efforts to improve targeted bioenergy crops are just beginning, very aggressive goals have been established for 

the use of these crops to meet the Nation’s fuel needs. Therefore, ASPB calls 

for additional funding that would be targeted to efforts to increase the utility 

and agronomic performance of bioenergy crops. 

—Although USDA has done some quality work with private foundations and other 

federal agencies such as the Department of Energy, more can be done. Earlier 

this year the National Science Foundation announced a partnership with the 

Bill and Melinda Gates Foundation on ‘‘Basic Research to Enable Agricultural 

Development (BREAD),’’ which will support basic research relevant to problems 

of agriculture in developing countries. 

Because USDA should be at the forefront of agricultural discovery, ASPB would 

like to see USDA create similar programs and be a part of similar endeavors with 

either private foundations or other research agencies in the future. 

Thank you for your consideration of our testimony on behalf of the American Society of Plant Biologists. Please do not hesitate to contact the American Society of 

Plant Biologists if we can be of any assistance in the future. For more information 

about the American Society of Plant Biologists, please see www.aspb.org. 

PREPARED STATEMENT OF THE AMERICAN SOCIETY OF AGRONOMY, CROP SCIENCE

SOCIETY OF AMERICA, AND SOIL SCIENCE SOCIETY OF AMERICA

The American Society of Agronomy (ASA), Crop Science Society of America 

(CSSA), and Soil Science Society of America (SSSA) are pleased to submit the following funding recommendations for fiscal year 2010. ASA, CSSA, and SSSA understand the challenges the Subcommittee on Agriculture, Rural Development, Food 

and Drug Administration, and Related Agencies faces with the tight budget for fiscal year 2010. We also recognize that the Agriculture Appropriations bill has many 

valuable and necessary components. We applaud the subcommittee’s efforts to fund 

mission-oriented, critical research through the USDA-Cooperative State, Research, 

Education and Extension Service, its intramural research portfolio funded through 

the Agricultural Research Service as well as the conservation programs supported 

through the Natural Resources Conservation Service. 
137 

ASA, CSSA, and SSSA are particularly grateful to the subcommittee for funding 

the Agriculture and Food Research Initiative (AFRI), the new competitive grants 

program for research, extension, and education within USDA’s Cooperative State 

Research, Education, and Extension Service at $201.5 million in the fiscal year 2009 

Omnibus Appropriations bill. In fiscal year 2010, at a time when our Nation needs 

to respond rapidly to challenges which threaten our ability to safely produce and 

distribute food, feed, fuel, and fiber, we believe it is essential to continue to build 

our competitive research programs. For this reason, we recommend funding AFRI 

at $300 million in the fiscal year 2010 agriculture appropriations bill. We believe 

that funding AFRI at this level would be a strong step in support of these important 

systems, enabling effective development and distribution of information which will 

achieve the goals of agricultural production (thereby maximizing the benefits of 

agroecosystem processes) and environmental stewardship. 

For the Agricultural Research Service (ARS), ASA, CSSA, and SSSA thank Congress for providing the agency with the much-needed investment of $176 million for 

buildings and facilities in the 2009 economic stimulus bill (Public Law 111–5). For 

fiscal year 2010, we recommend a funding level of $1,268 million or a 7 percent increase over the fiscal year 2009 enacted funding level. The ARS ensures that our 

Nation has a safe, reliable, and adequate supply of high quality food, feed, fiber and 

fuel. 

For the Cooperative State Research, Education and Extension Service (CSREES), 

ASA, CSSA, and SSSA recommend a funding level of $1,444 million for fiscal year 

2010, roughly an 18 percent increase over fiscal year 2009. Within CSREES we recommend an fiscal year 2010 funding level of $300 million for AFRI. 

For fiscal year 2010, ASA, CSSA, and SSSA support a 7 percent or $75.5 million 

increase over fiscal year 2009 enacted funding level of $1,036 million for the Natural 

Resources Conservation Service (NRCS), which would bring total funding for NRCS 

to $1,108 million. 

With more than 25,000 members and certified professionals, ASA, CSSA, and 

SSSA are the largest life science professional societies in the United States dedicated to the agronomic, crop and soil sciences. ASA, CSSA, and SSSA play a major 

role in promoting progress in these sciences through the publication of quality journals and books, convening meetings and workshops, developing educational, training, and public information programs, providing scientific advice to inform public 

policy, and promoting ethical conduct among practitioners of agronomy and crop and 

soil sciences. ASA and SSSA certified professionals—Certified Crop Advisers (CCA), 

Agronomists (CPAg) and Soil Scientists (CPSS)—are specialists who work in the 

field with farmers, providing technical advice about the agronomic practices—types 

and rates of fertilizer application, plant hybrid and variety selection, soil conservation, nutrient management, and integrated pest management—most appropriate to 

optimize crop yield and minimize environmental impact. 

Agricultural Research Service (ARS) 

ASA, CSSA, and SSSA applaud the Agricultural Research Service’s (ARS) ability 

to respond quickly to rapidly changing national needs. ARS’s 2,100 scientists located 

at 100 research locations accomplish scientific discoveries that help solve problems 

in crop and livestock production and protection and human nutrition, and ensure 

a sustainable interaction of agriculture and the environment. ARS National Programs focus on the importance, impact, and quality of ARS research in (1) Nutrition, Food Safety/Quality, (2) Animal Production and Protection, (3) Natural Resources and Sustainable Agricultural Systems, and (4) Crop Production and Protection. Increasingly, ARS through Cooperative Research and Development Agreements 

(CRADA) between Federal laboratories and businesses forms partnerships that help 

move new technologies to the marketplace. These partnerships are especially important to leverage during a time when our Nation’s economy remains vulnerable and 

Federal funding is constrained. Such cooperative research and development helps 

foster American businesses and enhances the position of the United States as a 

global leader in food, feed, fiber, and fuel production. 

ASA, CSSA, and SSSA find that research and technology transfer resulting from 

ARS programs ensures high-quality, safe food and other agricultural products; assesses the nutritional needs of Americans; helps to sustain a competitive agricultural economy; enhances the natural resource base and the environment; and provides economic opportunities for rural citizens, communities, and society as a whole. 

Again, ASA, CSSA, and SSSA recommend an ARS funding level of $1,268 million 

for fiscal year 2010, a 7 percent increase above the fiscal year 2009 enacted. 
138 

Cooperative State Research, Education, and Extension Service (CSREES) 

ASA, CSSA, and SSSA find that the need has never been greater to enhance investment in Hatch and McIntire-Stennis formula funding. Therefore, ASA, CSSA, 

and SSSA recommend that both Hatch and McIntire-Stennis receive a 10 percent 

increase over the fiscal year 2009 enacted level of funding, bringing the combined 

funding level to $258 million for fiscal year 2010. If we are to maintain the research 

capacity at our Nation’s Land Grant Universities and Colleges of Agriculture necessary to keep American agriculture and forestry competitive, while recognizing the 

potential of our managed systems to provide beneficial ecosystem services, we need 

concerted investment in capacity building at our institutions. 

Agriculture and Food Research Initiative (AFRI).—ASA, CSSA, and SSSA strongly 

endorse a 49 percent increase in funding for the Agriculture and Food Research Initiative. The AFRI, established in the Food, Conservation, and Energy Act of 2008 

(FCEA), is the successor to USDA’s National Research Initiative (NRI) and the Initiative for Future Agriculture and Food Systems (IFAFS). ASA, CSSA, and SSSA 

find that funding AFRI at $300 million in the fiscal year 2010 agriculture appropriations bill (exclusive of any funding identified for Section 406 programs) will show 

a strong commitment to America’s farmers and rural entrepreneurs. 

Bioenergy Feedstock Research.—ASA, CSSA, and SSSA support funding of the Agricultural Bioenergy Feedstock and Energy Efficiency Research and Extension Initiative (Section 7207) of the Food, Conservation and Energy Act of 2008 (FCEA) at 

$25 million for fiscal year 2010. Section 7207 is a new program which closes the 

critical research gap between fundamental biological discovery and the reliable expression of new traits in the field. The research and extension projects under Section 7207 are critical to the future of the United States, and will improve agricultural biomass production using field observations. This is a nearly priceless step in 

translation of basic research. Furthermore, we applaud Congress for including $118 

million in mandatory funding during the life of the FCEA for the Biomass Research 

and Development Initiative (BRDI). We are excited about the mandatory funding of 

the USDA portion of BRDI at $28 million for fiscal year 2010 and suggest that an 

additional $10 million in discretionary funding (it is authorized at $35 million) be 

placed towards this critical program for fiscal year 2010. 

Sustainable Agriculture Research and Education Programs.—ASA, CSSA, and 

SSSA find the SARE Professional Development Program to be an effective program 

and support funding for the program at $4.92 million for fiscal year 2010. Additionally, we urge the Subcommittee to consider an increase in SARE core funding to 

bring total funding to $15.7 million for fiscal year 2010. 

Higher Education.—ASA, CSSA, and SSSA urge the Subcommittee to fund the Institution Challenge Grants at $6.22 million for fiscal year 2010. We strongly support 

a fiscal year 2010 level of $4.24 million in funding for the Graduate Fellowships 

Grants; these grants enable us to train the next generation of scientific innovators. 

Cooperative Extension Service.—Extension forms a critical part of research, education and extension program integration, a feature unique to CSREES. Unfortunately, recently the Smith Lever 3(b) and 3(c) account has been flat-funded (in constant dollars this account has seen a gradual erosion in funding). ASA, CSSA, and 

SSSA support $309 million in appropriations for fiscal year 2010, a $20 million increase over fiscal year 2009 enacted, for the continuing education and outreach activities supported by Smith-Lever 3(b) & (c) formula funds. 

New Technologies for Ag Extension (NTAE).—eXtension is a national web-based 

information and education delivery system that provides direct public access to 

science-based educational resources. ASA, CSSA, and SSSA find that internet-facilitated outreach through extension and other New Technologies for Ag Extension 

(NTAE) programs provide invaluable consolidation and streamlining of information. 

These communication technologies help to highlight appropriate management, expediting the voluntary adoption of the best practices. ASA, CSSA, and SSSA recommend a 10 percent increase in appropriation for fiscal year 2010 for this program, 

bringing funding to $1.65 million. 

Integrated Research, Education, and Extension Competitive Grants Program.— 

Section 406 was initially authorized in the Agricultural Research, Extension and 

Education Reform Act of 1998. Since its inception this program has proven to be 

an indispensible part of water and pest management and numerous other issues. 

ASA, CSSA, and SSSA support a funding increase of 7 percent for programs under 

Section 406, which would bring total funding to $44.92 million. Furthermore, we 

strongly suggest that the International Science and Education (ISE) Grants Program also receive a 7 percent increase, bringing ISE funding to $3.21 million for 

fiscal year 2010, and increasing the funding of total integrated activities to $60 million for fiscal year 2010. 
139 

Organic Farming Transition Program.—ASA, CSSA, and SSSA urge the Sub- committee to fund the Organic Farming Transition Program at $1.97 million in fiscal year 2010, an increase over fiscal year 2009 of 7 percent. 

Natural Resources Conservation Service 

For fiscal year 2010, ASA, CSSA, and SSSA support a 7 percent increase over the fiscal year 2009 enacted funding level of $1,036 million for the Natural Resources 

Conservation Service. This would bring total NRCS funding to $1,108 million. 

Conservation Security Program.—The Conservation Security Program provides financial and technical assistance to producers who advance the conservation and improvement of soil, water, air, energy, plant and animal life, and other conservation 

purposes on Tribal and private working lands. ASA, CSSA, and SSSA applaud Congress for passing the FCEA which keeps this important working lands conservation 

program as an uncapped mandatory program. Further, ASA, CSSA, and SSSA encourage the Subcommittee not to cap appropriations for this program. 

Environmental Quality Incentives Program.—The Environmental Quality Incentives Program provides technical assistance to eligible farmers and ranchers to address soil, water, air, and related natural resource concerns on their lands in an environmentally beneficial and cost-effective manner. ASA, CSSA, and SSSA support 

funding of this essential program at $1,337 million for fiscal year 2010. 

In Summary 

A balance of funding mechanisms for research, including intramural, competitive 

and formula funding, is essential to maintain the capacity of the United States to 

conduct both basic and applied agricultural research to improve crop and livestock 

quality, and deliver safe and nutritious food products, while protecting and enhancing the Nation’s environment and natural resource base. In order to address these 

challenges and maintain our position in an increasingly competitive world, we must 

continue to support research, education and extension programs funded through the 

Agricultural Research Service and Cooperative State Research, Education, and Extension Service, and conservation programs supported by the Natural Resources 

Conservation Service. Congress must enhance funding for these programs to ensure 

that Americans have access to a safe and nutritious food supply and to provide for 

the next generation of research scientists, extension agents and educators. According to the USDA Economic Research Service (Agricultural Economic Report Number 

735), publicly funded agricultural research has earned an annual rate of return of 

35 percent. This rate of return suggests that additional allocation of funds to support research in the food and agricultural sciences would be highly beneficial to the 

U.S. economy. Finally, we must ensure support for CSREES-funded extension programs to guarantee that these important new tools and technologies reach and are 

utilized by producers and other stakeholders. 

As you lead the Congress in deliberation on funding levels for agricultural research, extension, education and conservation programs, please consider American 

Society of Agronomy, Crop Science Society of America, and Soil Science Society of 

America as supportive resources. We hope you will call on our membership and scientific expertise whenever the need arises. Thank you for your thoughtful consideration of our requests. For additional information or to learn more about the American Society of Agronomy, Crop Science Society of America and Soil Science Society 

of America (ASA–CSSA–SSSA), please visit www.agronomy.org, www.crops.org or 

www.soils.org or contact ASA–CSSA–SSSA Director of Science Policy Karl Glasener 

(kglasener@agronomy.org, kglasener@crops.org, or kglasener@soils.org) or 202–408– 

5382. 

PREPARED STATEMENT OF THE ANIMAL WELFARE INSTITUTE

USDA/APHIS/Animal Care (AC)/Animal Welfare Act (AWA) Enforcement 

AWI Request: $22,275,270 (near-level funding) 

Over the past decade, the subcommittee has responded to the urgent need for increased funding for Animal Care to improve its inspections of nearly 16,000 sites, 

including animal dealers, commercial breeders, laboratories, zoos, circuses, and airlines, to ensure compliance with Animal Welfare Act standards. AC now has 111 

inspectors (with 5 vacancies in the process of being filled), versus 64 inspectors at 

the end of the 1990s. During fiscal year 2008, they conducted 15,600 inspections, 

including required annual visits to all research facilities that alone house over 1 

million animals covered by the act. Moreover, AC inspectors engaged in extended, 

time-consuming follow-up with licensees/registrants regarded as problems because of 

the nature and frequency of their violations. 
140 

It is important to sustain the progress that has been made. This budget request 

of $22,275,270 provides a minimal increase over fiscal year 2009 to cover pay costs 

as well as the added responsibilities associated both with the growing number of 

licensed/registered facilities, and with enforcing the new Congressional ban on imports from foreign puppy mills. 

APHIS/Emergency Management Systems/Disaster Planning for Animals 

AWI Request: $1,001,000 (level funding) 

In addition to their AWA inspections, Animal Care personnel help plan and coordinate disaster response efforts for companion and service animals. In 2008, they 

assisted with pet evacuation and recovery during Hurricanes Gustav and Ike and 

the California wildfires. These efforts are required by law—laws enacted in recognition of the implications for disaster response, as learned during Hurricane Katrina, 

when people refuse to evacuate because no plans have been made for their companion animals. This is an important effort, and the additional funding is needed 

so that it does not come at the expense of AC’s other programs. 

Agricultural Research Service/National Agricultural Library (NAL)/Animal Welfare 

Information Center (AWIC) 

AWI Request: $1, 978,400 

We very much appreciate the Subcommittee’s strong support for the Animal Welfare Information Center, including placing it within the NAL’s budget as a line item. 

AWIC’s services are integral to the Nation’s biomedical research enterprise, as well 

as to other regulated entities, because they facilitate compliance with Federal animal welfare regulations and policies governing animal-related research. The AWIC 

helps to improve the conduct of research, including the care provided to the animals 

who are used, thereby ensuring a reduction in variables that can skew the research. 

Better science is the end result. 

Congress established AWIC under the Improved Standards for Laboratory Animals Act (the 1985 amendment to the Animal Welfare Act) to serve as a clearinghouse, training center, and educational resource for institutions using animals in research, testing, and teaching. The Center is the single most important resource for 

helping personnel at more than 1,200 United States research facilities meet their 

responsibilities under the AWA. Supported by a modest funding level, its services 

are available to everyone at these institutions, including animal technicians, research investigators, attending veterinarians, IACUC representatives, and the Institutional Official, as well as to other industries and regulated entities, USDA inspectors, and the general public. 

AWIC provides data on the following: alleviating or reducing pain and distress in 

experimental animals (including anesthetic and analgesic procedures); reducing the 

number of animals used for research where possible; identifying alternatives to the 

use of animals for specific research projects; and preventing the unintended duplication of animal experiments. The Center collects, updates, and disseminates material 

on humane animal housing and husbandry, the responsibilities of Institutional Animal Care and Use Committees (IACUCs), animal behavior, improved methodologies, 

psychological well-being of primates, and exercise for dogs. Through the resources 

it provides to the research community and other animal industries, such as zoos, 

AWIC contributes significantly to science-based decision-making in animal care. 

AWIC’s website (http://awic.nal.usda.gov/) is one of the most accessed sites at the 

NAL, with an average of over 340,000 page-views per month in fiscal year 2008, a 

12 percent increase over fiscal year 2007. It provides valuable information on issues 

of importance not only to the science community but also to the agriculture and public health communities, including BSE and avian influenza, two of the top areas of 

inquiry for visitors to its website. In fiscal year 2008, in addition to hundreds of millions of kbytes of information downloaded from the website, more than 82,000 hard 

copies (paper and CD) were distributed, an increase of 17 percent over fiscal year 

2007. This includes the distribution of the AWIC Bulletin to over 7,000 requestors. 

AWIC staff provided over 2,000 personal reference services; conducted 7 sessions of 

its workshop ‘‘Meeting the Information Requirements of the Animal Welfare Act’’ at 

universities, pharmaceutical/research firms, and NAL itself; and conducted 22 exhibitions and/or presentations at various professional and scientific meetings, as well 

as for several visiting delegations at NAL. 

AWIC expertise is also needed to address continuing deficiencies in IACUC oversight within research institutions. First identified some years ago in an OIG audit, 

USDA found IACUC-related violations 45 times in fiscal year 2007, and the primate 

abuse documented at the New Iberia Research Facility in 2008 provides fresh evidence of these problems. AWIC needs the funds to conduct more of its workshops, 
141 

and to achieve a long-sought objective of holding a symposium on AWA requirements for IACUC nonaffiliated members (i.e., members from the community charged 

with representing the communities’ concerns for the animals). 

Likewise, increased funding is necessitated by the expansion of AWIC’s mandate 

to serve the broader industry regulated under the AWA: animal dealers, carriers 

and handlers, zoos and other exhibitors. Animal Care’s veterinary medical officers 

and animal care inspectors are able to utilize the full range of AWIC’s services to 

better fulfill their responsibilities. The AWIC works closely with Animal Care and 

with Emergency Veterinary Services on emerging crises such as the highly pathogenic avian influenza, and it also quickly responded to the current health emergency 

by adding a variety of information resources on the H1N1 virus to its website, its 

blog, and through Twitter. 

Among other endeavors, the $1.978 million would be used as follows: The addition 

of two much-needed specialists to expand the content of the Center’s database and 

make it more user-friendly and searchable; development of web-based training modules to provide online delivery of training opportunities; workshops, in conjunction 

with Animal Care, to assist licensees and registrants frequently cited for AWA violations; acquisition of, including electronic access to, data, including certain veterinary 

publications (the receipt of which was discontinued due to budget shortfalls); restoration of a grants program that could be used to update essential publications and 

manuals and translate them into Spanish for the growing number of Spanish-speaking animal care personnel in labs and zoos; and the overhead that must be provided 

to the Agricultural Research Service and the National Agricultural Library. (It 

should be noted that, after salaries and benefits, the largest single expense AWIC 

has is its overhead costs to ARS and NAL, which comprise over 13 percent of this 

funding request. This large expense substantially reduces the funds available for 

AWIC to conduct programs and provide services.) 

AWIC’s indispensability not only in assisting with compliance with the AWA but 

also in providing up-to-date information on a range of issues, from BSE to primate 

enrichment to the H1N1 virus, that are critical to the scientific and agricultural 

communities and the general public, justifies this modest proposed increase in its 

budget to enable it to meet growing demand for its expertise on multiple fronts. 

Food Safety and Inspection Service (FSIS)/Humane Methods of Slaughter Act 

(HMSA) Enforcement 

AWI Request: Sufficient Funds to Ensure Strengthened Enforcement of HMSA 

We greatly appreciate Congress’ past efforts to address USDA’s egregious failure 

to enforce the Humane Methods of Slaughter Act. Despite these efforts, USDA has 

made no improvement in this area. This failure jeopardizes both animal welfare and 

consumer welfare. 

Since 2001, Congress has provided millions in additional funds for humane 

slaughter enforcement, in part to be used to hire new in-plant employees to work 

full-time on HMSA enforcement only. However, to date, none have been hired solely 

to handle this responsibility. 

An AWI report found that enforcement of humane slaughter law is a low priority 

within USDA. (Crimes without Consequences: The Enforcement of Humane Slaughter Laws in the United States. www.awionline.org/farm/pdf/SlaughterReport.pdf) 

Not much has changed since 2004, when the Government Accountability Office 

issued a report citing widespread animal welfare issues under USDA’s watch. It appears that the agency ignored the report. 

Between 2002 and 2005, only 42 enforcement actions beyond deficiency reports for 

noncompliance with humane slaughter laws were taken in the United States. But 

whistleblower accounts and undercover videotape documentation from inside slaughterhouses reviewed in the report suggest that the current low level of humane enforcement is not due to a lack of violations. Instead, crimes are either not observed 

or recognized by inspection personnel, not reported through the proper channels, or 

the appropriate remedial measures are not taken. 

In 2008, undercover video obtained by an investigator from an animal protection 

group revealed abhorrent acts of cruelty to livestock at the Westland/Hallmark Meat 

Packing Company in Chino, Calif., raising both ethical and food safety issues. 

In the wake of this case, suggestions have been made regarding the installation 

of video cameras as a deterrent. AWI urges Congress to reject any attempt by the 

department to use cameras in lieu of inspectors. 

Inspectors must be able to observe animals from the time the truck arrives and 

animals are unloaded and moved, through the stunning and slaughter process, until 

the last animal on the vehicle is killed. Under the law, when an inspector sees an 

apparent violation, he/she is authorized to stop the line on the spot. 
142 

AWI is concerned with USDA’s lack of commitment to enforcement. Congress 

must provide enough funding to allow FSIS to assign as many inspectors as needed 

to fully enforce the HMSA at all slaughter plants, but then it must exercise its oversight power to make sure that those inspectors are in fact tasked only with HMSA 

enforcement, are adequately trained, and that they understand their mission: To enforce the law and to ensure the humane and safe treatment of animals killed for 

human consumption, as mandated by the HMSA. 

Office of Inspector General (OIG)/Animal Fighting Enforcement 

AWI Request: $87,910,150 (near-level funding) 

In 2007, violations of the AWA’s animal fighting provisions, as well as the possession of related implements, became felonies. AWI supports funding OIG sufficiently 

to allow it to pursue animal fighting cases vigorously. Animal fighting is often associated with other violent crimes, thus posing a threat to the welfare of both animals 

and our communities. This level of funding is also needed to enable OIG to carry 

out audits and investigations to improve compliance with the Animal Welfare Act, 

the Humane Methods of Slaughter Act, the Horse Protection Act, and the downed 

animal rules. 

APHIS/Animal Care/Horse Protection Act (HPA) Enforcement 

AWI Request: $1 million 

The goal of the Horse Protection Act, passed in 1970, is to end the cruel practice 

of soring, by which unscrupulous owners and/or trainers primarily of Tennessee 

Walking Horses intentionally inflict pain on the legs and hooves of horses, through 

the application of chemical and mechanical irritants, to produce an exaggerated 

gait. In 2008, the American Association of Equine Practitioners condemned soring 

as ‘‘one of the most significant welfare issues faced by the equine industry.’’ Three 

Girl Scouts bravely documented the brutality of this crime in their video ‘‘See it 

through my eyes.’’ (Available at www.youtube.com/watch?v=kqFeYu1CrjU) 

Throughout its history, however, the law has been openly flouted and inadequate 

funding has hampered enforcement. Through a separate, joint statement with the 

Humane Society of the United States and others, we support a request for $1 million for HPA enforcement. This sum would allow government oversight at many 

more horse shows and greater investment in technologies (gas chromatography/mass 

spectrometry and thermography) that improve detection of sored horses. It should 

be noted that in fiscal year 2007, the use of GC/MS, which detects foreign substances used to sore horses, resulted in positive findings in 50 percent of the animals tested. 

APHIS/Investigative and Enforcement Services (IES) 

AWI Request: $14,036,350 (near-level funding) 

The Investigative and Enforcement Services division of APHIS is essential to 

meaningful enforcement of the AWA and HPA. Among other things, it investigates 

alleged violations of the AWA and undertakes appropriate enforcement action. It 

handles more animal welfare cases as new facilities become licensed and registered 

and Animal Care conducts more inspections. Moreover, IES has seen an increase in 

its workload involving HPA-related activities. 

PREPARED STATEMENT OF THE ANIMAL WELFARE INSTITUTE

Re: Request of $1,978,400 for the Animal Welfare Information Center 

Dear Chairman Kohl and Ranking Member Cochran: Thank you for your interest 

in and efforts on behalf of the Animal Welfare Information Center (AWIC) at the 

National Agricultural Library (NAL). Previous efforts to eliminate AWIC have failed 

as a result of Congress’ appreciation of the agency’s value to the research community and it support for its programs. 

The AWIC was established in 1986 in response to a mandate in the Improved 

Standards for Laboratory Animals amendment to the Animal Welfare Act (AWA). 

The Center serves as a clearinghouse, training center, and education resource for 

those involved in the use of animals for research, testing, and teaching (as well as 

other entities covered by the AWA), and the need and demand for its services continue to outstrip its resources. AWIC provides training and compiles, distributes, 

and posts on its website information resources from the scientific literature to assist 

researchers who use animals. The subjects covered include husbandry, handling, 

and care of animals; personnel training; animal behavior; alternatives; improved 

methodologies; environmental enrichment of non-human primates; and pain control 
143 

via anesthesia and analgesia. It also serves as a resource for the wider scientific 

and agricultural communities by providing access to material on zoonotic diseases 

such as avian influenza, transmissible spongiform encephalopathies, tuberculosis, 

and now the H1N1 virus. Its activities contribute significantly to science-based decision-making in animal care. 

In fiscal year 2008, staff conducted seven sessions of AWIC’s workshop, ‘‘Meeting 

the Information Requirements of the Animal Welfare Act’’ (evaluations of which are 

overwhelmingly positive, with participants indicating a high degree of new information acquisition), and presented 22 exhibitions and presentations. The AWIC 

website (http://awic.nal.usda.gov/) is one of the most accessed sites at NAL, with an 

average of over 340,000 page-views each month in fiscal year 2008, a 12 percent increase over fiscal year 2007. Many improvements to the website have been made 

in the past year, and more information on more subjects through more outlets is 

available. 

Today we write in support of an appropriation of $1,978,400, which is urgently 

needed to fund, in addition to salaries and other expenses, AWIC’s services and its 

ongoing efforts to improve their delivery: 

—$50,000—Develop web-based training modules, including interactive modules, in 

order to provide online delivery of training opportunities. 

—$36,000—Present workshops in cooperation with Animal Care to assist licensees/registrants frequently cited for AWA violations. 

—$20,500—Internet services 

—$13,900—AWIC staff training 

—$200,000—Resume acquisition of veterinary publications that NAL discontinued 

5 years ago, and increase the pace of indexing all such publications. 

—$270,000—Overhead to ARS and NAL 

—$50,000—Meet Congressional mandate to digitize more materials; in particular, 

scanning AWA-related documents going back to 1966 

—$50,000—Restore a grants program that could be used to update Essentials for 

Animals in Research, as well as certain animal care manuals, and then translate them into Spanish; develop training DVDs, etc. In the past, this program 

yielded useful products, including the original Essentials for Animal Research: 

A Primer for Research Personnel (which was also translated into Spanish and 

is still among the top ten downloaded documents); a video on normal animal 

behaviors; and a training video on using animals in research. It also provided 

support for the first World Congress on Animal Use in the Life Sciences, and 

for the proceedings of conferences for the Scientists Center for Animal Welfare. 

—$10,000—Convene a stakeholders meeting to assess AWIC’s services and recommend steps for the future. 

—$5,000—Translate the AWA and its regulations, and other documents, into 

Spanish. 

The growing numbers of Spanish-speaking animal-care personnel in U.S. research 

facilities and zoos, as well as increasing interest on the part of scientific communities in Central and South America, have made the availability of Spanish-language materials a priority. 

We hope that the new Administration recognizes how vitally important the 

AWIC’s services are to the nation’s biomedical research enterprise, and how essential it is to have a budget sufficient to support these services and technological improvements in their delivery. AWIC facilitates compliance with specific requirements of federal animal welfare regulations and policies governing animal-related 

research. In addition, it provides extensive research services for us, thereby greatly 

benefiting our work on animal research issues. We appreciate and look forward to 

a continued working relationship with the Animal Welfare Information Center and 

hope you will support our modest request for appropriations. 

PREPARED STATEMENT OF THE COLORADO RIVER BASIN SALINITY CONTROL FORUM

The Congress concluded that the Colorado River Basin Salinity Control Program 

(Program) should be implemented in the most cost-effective way. The Program is 

funded by EQIP, the U.S. Bureau of Reclamation’s (BOR) Basinwide Program, and 

a cost share for both of these programs provided by the Basin States. Realizing that 

agricultural on-farm strategies were some of the most cost-effective strategies, the 

Congress authorized a program for the United States Department of Agriculture 

(USDA) through amendment of the Colorado River Basin Salinity Control Act (Act) 

in 1984. With the enactment of the Federal Agriculture Improvement and Reform 

Act of 1996 (FAIRA), the Congress directed that the Program should continue to be 

implemented as one of the components of the Environmental Quality Incentives Pro-
144 

gram (EQIP). Since the enactment of the Farm Security and Rural Investment Act 

(FSRIA) in 2002, there have been, for the first time in a number of years, opportunities to adequately fund the Program within the EQIP. In 2008, Congress passed the 

Food, Conservation, and Energy Act (FCEA). The FCEA addresses the cost sharing 

required from the Basin Funds. In so doing, the FCEA named the cost sharing requirement as the Basin States Program (BSP). The BSP will provide 30 percent of 

the total amount that will be spent each year by the combined EQIP and BSP effort. 

The Program, as set forth in the act, is to benefit Lower Basin water users hundreds of miles downstream from salt sources in the Upper Basin as the salinity of 

Colorado River water increases as the water flows downstream. There are very significant economic damages caused by high salt levels in this water source. 

Agriculturalists in the Upper Basin where the salt must be controlled, however, 

don’t first look to downstream water quality standards but look for local benefits. 

These local benefits are in the form of enhanced beneficial use and improved crop 

yields. They submit cost-effective proposals to the State Conservationists in Utah, 

Wyoming and Colorado and offer to cost share in the acquisition of new irrigation 

equipment. It is the act that provides that the seven Colorado River Basin States 

will also cost share with the Federal funds for this effort. This has brought together 

a remarkable partnership. 

After longstanding urgings from the States and directives from the Congress, the 

USDA has concluded that this program is different than small watershed enhancement efforts common to the EQIP. In the case of the Colorado River salinity control 

effort, the watershed to be considered stretches more than 1,200 miles from the river’s headwater in the Rocky Mountains to the river’s terminus in the Gulf of California in Mexico and receives water from numerous tributaries. The USDA has determined that this effort should receive a special funding designation and has appointed a coordinator for this multi-state effort. 

In recent fiscal years, the Natural Resources Conservation Service (NRCS) has directed that about $19 million of EQIP funds be used for the Program. The Colorado 

River Basin Salinity Control Forum (Forum) appreciates the efforts of the NRCS 

leadership and the support of this subcommittee. The plan for water quality control 

of the Colorado River was prepared by the Forum, adopted by the States, and approved by the United States Environmental Protection Agency (EPA). The Colorado 

River Basin Salinity Control Advisory Council has taken the position that the funding for the salinity control program should not be below $20 million per year. Over 

the last 3 fiscal years, for the first time, funding almost reached the needed level. 

State and local cost-sharing is triggered by the Federal appropriation. In fiscal year 

2009, it is anticipated that the States will cost share with about $8 million and local 

agriculture producers will add more than $7 million. Hence, it is anticipated that 

in fiscal year 2009 the State and local contributions will be about 45 percent of the 

total program cost. 

Over the past few years, the NRCS has designated that about 2.5 percent of the 

EQIP funds be allocated to the Colorado River salinity control program. The Forum 

believes this is the appropriate future level of funding as long as the total EQIP 

funding nationwide is more than $1 billion. Funding above this level assists in offsetting pre-fiscal year 2003 funding below this level. The Basin States have cost 

sharing dollars available to participate in funding on-farm salinity control efforts. 

The agricultural producers in the Upper Basin are waiting for their applications to 

be considered so that they might improve their irrigation equipment and also cost 

share in the Program. 

Overview 

The Program was authorized by the Congress in 1974. The Title I portion of the 

act responded to commitments that the United States made, through a Minute of 

the International Boundary and Water Commission, to Mexico specific to the quality 

of water being delivered to Mexico below Imperial Dam. Title II of the act established a program to respond to salinity control needs of Colorado River water users 

in the United States and to comply with the mandates of the then newly-enacted 

Clean Water Act. This testimony is in support of funding for the Title II program. 

After a decade of investigative and implementation efforts, the Basin States concluded that the act needed to be amended. The Congress agreed and made a major 

revision to the act in 1984. That revision, while keeping the Department of the Interior as lead coordinator for Colorado River Basin salinity control efforts, also gave 

new salinity control responsibilities to the USDA. The Congress has charged the Administration with implementing the most cost-effective program practicable (measured in dollars per ton of salt controlled). It has been determined that the agricultural efforts are some of the most cost-effective opportunities. 
145 

Since Congressional mandates of more than three decades ago, much has been 

learned about the impact of salts in the Colorado River system. The BOR has conducted studies on the economic impact of these salts. The BOR recognizes that the 

damages to United States’ water users alone are hundreds of millions of dollars per 

year. 

The Forum is composed of gubernatorial appointees from Arizona, California, Colorado, Nevada, New Mexico, Utah and Wyoming. The Forum has become the sevenState coordinating body for interfacing with Federal agencies and the Congress in 

support of the implementation of the Salinity Control Program. In close cooperation 

with the EPA and pursuant to requirements of the Clean Water Act, every 3 years 

the Forum prepares a formal report evaluating the salinity of the Colorado River, 

its anticipated future salinity, and the program elements necessary to keep the salinity concentrations (measured in Total Dissolved Solids—TDS) at or below the levels measured in the river system in 1972 at Imperial Dam, and below Parker and 

Hoover Dams. 

In setting water quality standards for the Colorado River system, the salinity concentrations at these three locations in 1972 have been identified as the numeric criteria. The plan necessary for controlling salinity and reducing downstream damages 

has been captioned the ‘‘Plan of Implementation.’’ The 2008 Review of water quality 

standards includes an updated Plan of Implementation. In order to eliminate the 

shortfall in salinity control resulting from inadequate Federal funding for a number 

of years from the USDA, the Forum has determined that implementation of the Program needs to be accelerated. The level of appropriation requested in this testimony 

is in keeping with the agreed upon plan. If adequate funds are not appropriated, 

significant damages from the higher salt concentrations in the water will be more 

widespread in the United States and Mexico. 

Concentrations of salts in the river cause well over $300 million in quantified 

damages and significantly more in unquantified damages in the United States and 

result in poorer quality water being delivered by the United States to Mexico. Damages occur from: 

—a reduction in the yield of salt sensitive crops and increased water use for leaching in the agricultural sector, 

—a reduction in the useful life of galvanized water pipe systems, water heaters, 

faucets, garbage disposals, clothes washers, and dishwashers, and increased use 

of bottled water and water softeners in the household sector, 

—an increase in the use of water for cooling, and the cost of water softening, and 

a decrease in equipment service life in the commercial sector, 

—an increase in the use of water and the cost of water treatment, and an increase 

in sewer fees in the industrial sector, 

—a decrease in the life of treatment facilities and pipelines in the utility sector, 

—difficulty in meeting wastewater discharge requirements to comply with National Pollutant Discharge Elimination System permit terms and conditions, 

and an increase in desalination and brine disposal costs due to accumulation 

of salts in groundwater basins, and 

—increased use of imported water for leaching and cost of desalination and brine 

disposal for recycled water. 

State Cost Sharing and Technical Assistance 

The authorized cost sharing by the Basin States, as provided by FAIRA, was at 

first difficult to implement as attorneys for the USDA concluded that the Basin 

States were authorized to cost share in the effort, but the Congress had not given 

the USDA authority to receive the Basin States’ funds. After almost a year of exploring every possible solution as to how the cost sharing was to occur, the States, 

in agreement with Reclamation, State officials in Utah, Colorado and Wyoming and 

with NRCS State Conservationists in Utah, Colorado and Wyoming, agreed upon a 

program parallel to the salinity control activities provided by the EQIP wherein the 

States’ cost sharing funds are being contributed and used. We now have several 

years of experience with that program and with the passage of FCEA we now have 

a clear authority for this program that is now known as the BSP. 

The act designates that the Secretary of the Interior provide the coordination for 

the Federal agencies involved in the salinity control program. That responsibility 

has been delegated to the BOR. The BOR administers the Basin States cost sharing 

funds that have been used in the Parallel Program. The BOR requested that there 

be enacted clearer authority for the use of these funds. 

With respect to the use of Basin States’ cost sharing funds in the past, the Basin 

States felt that it was most essential that a portion of the Program be associated 

with technical assistance (TA) and education activities in the field. Without this necessary support, there is no advanced planning, proposals are not well prepared, as-
146 

sertions in the proposals cannot be verified, implementation of contracts cannot be 

observed, and valuable partnering and education efforts cannot occur. Recognizing 

these values, the BSP designates 40 percent of the funds available on these needed 

TA activities made possible by contracts with the NRCS. 

PREPARED STATEMENT OF THE COLORADO RIVER BOARD OF CALIFORNIA

This testimony is in support of funding for the U.S. Department of Agriculture 

(USDA) with respect to its on-farm Colorado River Basin Salinity Control Program 

for fiscal year 2010. This program has been carried out through the Colorado River 

Basin Salinity Control Act (Public Law 93–320), since it was enacted by Congress 

in 1974. With the enactment of the Federal Agricultural Improvement and Reform 

Act (FAIRA) in 1996 (Public Law 104–127), specific funding for salinity control 

projects in the Colorado River Basin were eliminated from the Federal budget and 

aggregated into the Department of Agriculture’s Environmental Quality Incentives 

Program (EQIP) as one of its program components. With that action, Congress concluded that the salinity control program could be more effectively implemented as 

one of the components of the EQIP. 

The Program, as set forth in the act, benefits both the Upper Basin water users 

through more efficient water management and the Lower Basin water users, hundreds of miles downstream from salt sources in the Upper Basin, through reduced 

salinity concentration of Colorado River water. California’s Colorado River water 

users are presently suffering economic damages in the hundreds of million of dollars 

per year due to the River’s salinity. 

The Colorado River Board of California (Colorado River Board) is the State agency 

charged with protecting California’s interests and rights in the water and power resources of the Colorado River system. In this capacity, California along with the 

other six Colorado River Basin states through the Colorado River Basin Salinity 

Control Forum (Forum), the interstate organization responsible for coordinating the 

Basin States’ salinity control efforts, established numeric criteria in June 1975 for 

salinity concentrations in the River. These criteria were established to lessen the 

future damages in the Lower Basin States of Arizona, California, and Nevada, as 

well as assist the United States in delivering water of adequate quality to Mexico 

in accordance with Minute 242 of the International Boundary and Water Commission. 

The goal of the Colorado River Basin Salinity Control Program is to offset the effects of water resources development in the Colorado River Basin after 1972 as each 

state develops its Colorado River Compact apportionments. In close cooperation with 

the U.S. Environmental Protection Agency (EPA) and pursuant to requirements of 

the Clean Water Act (Public Law 92–500), every 3 years the Forum prepares a formal report analyzing the salinity of the Colorado River, anticipated future salinity, 

and the program elements necessary to keep the salinity concentrations (measured 

in Total Dissolved Solids—TDS) at or below the levels measured in the Colorado 

River system in 1972 at Imperial Dam, and below Parker and Hoover Dams. The 

latest report was prepared in 2008 titled: 2008 Review, Water Quality Standards 

for Salinity, Colorado River System (2008 Review). The plan necessary for controlling salinity and reducing downstream damages has been captioned the ‘‘Plan of Implementation.’’ The 2008 Review includes an updated Plan of Implementation. 

Concentrations of salts in the River annually cause about $376 million in quantified damage in the United States (there are significant un-quantified damages as 

well). For example, damages occur from: 

—A reduction in the yield of salt sensitive crops and increased water use for 

leaching in the agricultural sector; 

—A reduction in the useful life of galvanized water pipe systems, water heaters, 

faucets, garbage disposals, clothes washers, and dishwashers, and increased use 

of bottled water and water softeners in the household sector; 

—An increase in the use of water for cooling, and the cost of water softening, and 

a decrease in equipment service life in the commercial sector; 

—An increase in the use of water and the cost of water treatment, and an increase in sewer fees in the industrial sector; 

—A decrease in the life of treatment facilities and pipelines in the utility sector; 

—Difficulty in meeting wastewater discharge requirements to comply with National Pollutant Discharge Elimination System permit terms and conditions, 

and an increase in desalination and brine disposal costs due to accumulation 

of salts in groundwater basins, and fewer opportunities for recycling due to 

groundwater quality deterioration; and 
147 

1 A vision for a National Geographic Information System, by Jack Dangermond and Anne Hale 

Miglarese. 

—Increased use of imported water for leaching and the cost of desalination and 

brine disposal for recycled water. For every 30 milligram per liter increase in salinity concentrations, there are $75 

million in additional damages in the United States. Although the Program, thus far, 

has been able to implement salinity control measures that comply with the approved 

plan, recent drought years have caused salinity levels to rise in the River. Predictions are that this will be the trend for the next several years. This places an 

added urgency for acceleration of the implementation of the Program. 

Enactment of the Farm Security and Rural Investment Act of 2002 provided an 

opportunity to adequately fund the Salinity Program within EQIP. The Colorado 

River Basin Salinity Control Advisory Council has taken the position that the USDA 

portion of the effort be funded at 2.5 percent of the EQIP funding but at least $20 

million annually. Over the past few years, the Natural Resources Conservation 

Service (NRCS) has designated 2.5 percent of EQIP funds be allocated to the Colorado River Salinity Control program. The Forum suggests that this is an appropriate level of funding as long as it does not drop below $20 million. The Colorado 

River Board supports the recommendation of the Forum and urges this Subcommittee to support funding for the Colorado River Basin Salinity Control Program 

for 2010 at this level. 

These Federal dollars will be augmented by the State cost sharing of 30 percent 

with an additional 25 percent provided by the agricultural producers with whom 

USDA contracts for implementation of salinity control measures. Over the past 

years, the Colorado River Basin Salinity Control program has proven to be a very 

cost effective approach to help mitigate the impacts of increased salinity in the Colorado River. Continued Federal funding of this important Basin-wide program is essential. 

In addition, the Colorado River Board recognizes that the Federal Government 

has made significant commitments to the Republic of Mexico and to the seven Colorado River Basin States with regard to the delivery of quality water to Mexico. In 

order for those commitments to continue to be honored, it is essential that in fiscal 

year 2010, and in future fiscal years, that Congress continues to provide funds to 

USDA to allow it to provide needed technical support to agricultural producers for 

addressing salinity control in the Basin. 

The Colorado River is, and will continue to be, a major and vital water resource 

to the 18 million residents of southern California as well as throughout the Colorado 

River Basin. As stated earlier, preservation and improvement of the Colorado River 

water quality through an effective salinity control program will avoid the additional 

economic damages to users of Colorado River water in California, Arizona, and Nevada. 

PREPARED STATEMENT OF THE ENVIRONMENTAL SERVICE RESEARCH INSTITUTE

A PROPOSAL FOR NATIONAL ECONOMIC RECOVERY—AN INVESTMENT IN GEOSPATIAL

INFORMATION INFRASTRUCTURE BUILDING A NATIONAL GIS 1

Summary 

We respectfully request the Subcommittee’s support for a multi-year, governmentwide effort to build a national Geospatial Information System (GIS), led by the Secretary of Interior through his role as chairman of the Federal Geographic Data 

Committee under OMB circular A–16, and the United States Geological Survey. The 

total cost of the program, as detailed below, is expected to be approximately $1.2 

billion spread over 3 years. For fiscal 2010, we urge the Subcommittee to provide 

$40.1 million for the portions of this project within your jurisdiction. 

Proposal 

The Stimulus Plan recently approved by Congress and the incoming Obama Administration is an enormous undertaking to revive the American economy. Potentially, it will involve thousands of infrastructure and other projects intended to create jobs and restart economic growth while producing things of lasting value to 

American taxpayers. The challenge to properly manage and execute this effort will 

be daunting, requiring unprecedented access to data and information at all levels 

of government and the private sector. 

This is the moment for America to build a national Geographic Information System (GIS), that is, a unified, up-to-date, publicly-accessible national digital map, en-
148 

riched with data from all available sources, and supported by GIS technology. This 

system can be built quickly, immediately creating high tech jobs, and will serve as 

a public resource for project planners to support transportation infrastructure, alternative energy research, and project siting. It will also provide a foundation for monitoring the U.S. economic recovery across our communities, allowing activities to get 

underway as soon as possible and leaving a legacy for the future. 

The benefits of a national GIS are universal. The Western Governor’s Association 

declared GIS a key component of our national critical infrastructure. The National 

Geospatial Advisory Committee (NGAC) adopted a set of transition recommendations that represent a broad consensus among the key public and private stakeholders in the geospatial technology field and form a principal basis for this proposal. 

Why a National GIS Should be Completed 

Agencies have been laying the foundation for national GIS for years. It falls within umbrella names like Imagery for the Nation, The National Map, the National 

Spatial Data Infrastructure, and the pioneering work of by the U.S. Geological Survey, the Department of Commerce Census Bureau and the National Oceanic and Atmospheric Administration and the Departments of Homeland Security, Agriculture, 

and Interior, among others. It is supported by technical studies from the National 

Geospatial Advisory Committee (NGAC), the National Research Council, the Federal 

Geographic Data Committee (FGDC), and the National States Geographic Information Council (NSGIC). Now is the time to pull them together. 

GIS technology is uniquely capable of providing unity both to the complex new 

Stimulus Plan as well as other ongoing initiatives. GIS can integrate data from 

agencies across all levels of government, providing decision makers a powerful tool 

to marshal knowledge on items as diverse as personnel, finance, economics, infrastructure, and resources, all organized within maps or images showing geographic 

basics such as topography, roads, parcels, buildings, utility networks, landmarks, 

soil types, and political and physical land divisions. It brings together all key national datasets to support action—which is why it is considered a must for emergency response organizations across the country. A national GIS will place at our 

fingertips a comprehensive description of our nation’s assets, resources and operations, all linked geographically. Once completed, it will be a priceless national resource and an indispensable tool for planners and business alike. 

A national GIS can be built immediately, engaging hundreds of private firms. It 

will speed the start of job-rich infrastructure projects. Its biggest impact will be on 

projects critical to energy development, homeland security, defense, climate change, 

health care delivery, telecommunications, transportation, and the environment. 

Without national GIS as a management tool, efforts will be haphazard and project 

planners will be hamstrung. A National GIS must be a cornerstone program funded 

by the Stimulus Plan, a fulcrum to wring the greatest result for each dollar spent. 

Technical fundamentals of a National GIS 

A GIS system integrates information from many sources and authors using standardized protocols so that information can be harmonized and incorporated into a 

consistent framework to support multiple missions at all levels of government and 

private business. It can be built and maintained largely using on-going business 

processes such as The National Map initiative of Interior Department’s Geological 

Survey (USGS), and it can rely heavily on existing software, hardware, and networks, integrated by a lead organization setting standards and protocols. Existing 

modern GIS server technology, together with open standards and Services Oriented 

Architecture (SOA), can provide enabling components for a national GIS immediately. This architecture maximizes collaboration among government and private 

entities. Guarantees of privacy, confidentiality, protection of proprietary financial 

data, and similar concerns can be built in at the foundation and at every level. This 

national system will result in the following: 

—A series of standard geographic datasets (framework layers described below); 

—A series of workflows that transactionally maintain (update) these datasets; 

—A system for data management responsibility (FGDC governance); 

—A suite of tailored applications; 

—A designated Federal entity to oversee the effort; 

—The necessary technology to support a National GIS system. 

Leadership and cost for a National GIS 

Both the National Geospatial Advisory Committee (NGAC) and the Department 

of Interior have developed detailed recommendations on how to build a National 

GIS. A key first step is to implement fully the Imagery for the Nation initiative, 

an intergovernmental plan to create a full Federal-level GIS based on nationwide 
149 

aerial imaging and mapping, participation by agencies across the Federal landscape, 

and technological consistency. 

Next, a comprehensive national updating of mapping and topographical information is essential to create a complete current portrait of America—what is referred 

to as The National Map. This step, along with outreach to incorporate key additional databases maintained by State and local governments and the private sector, 

and elements such as Parcels, Transportation, Hydro, Elevation, Critical Habitat 

and Boundaries, will be needed to make the system most effective for project decision-makers and infrastructure planners. We anticipate the total cost to be approximately $1.2 billion, spread over 3 years. We can provide detailed cost breakdowns 

upon request. 

In order to create a national GIS it is necessary to update and integrate the many 

currently-existing individual agency map layers into a consistent, integrated whole. 

USGS would lead this effort and combine information into a consistent geospatial 

foundation. This component will, over the next 3 years, require an additional $200 

million spread over a variety of Federal Departments and Agencies. 

Interagency plans, contracts, and management systems are already in place today 

to implement this initiative. Overall management could be provided by the Secretary of the Interior, who chairs the Federal Geographic Data Committee, with significant involvement from USDA, DOC and DHS/FEMA. In addition, program funding can be leveraged through cooperative efforts with partners in State and local 

government and the private sector. The National Geospatial Advisory Committee 

can provide ongoing strategic and recommendations program design and implementation. 

A National GIS: Key Framework Data and System Technology 

We propose focusing on the development of five key digital layers or initiatives 

as initial steps toward a National GIS: Imagery, Parcel Data, Elevation, and Wildlife Habitat, and Recovery.gov. 

—Imagery.—Imagery for the Nation (IFTN) is an intergovernmental initiative to 

address the Nation’s basic business needs for aerial images. Imagery is used for 

countless applications in all levels of government and the private sector, embraced by the public through online tools such as Google Earth and Microsoft 

Virtual Earth. Partnerships between levels of government to acquire imagery 

data have lowered costs, reduced duplication, and allowed greater data standardization. IFTN will maximize the impact of taxpayer investments through a 

coordinated national acquisition program. The IFTN initiative was originated by 

the National States Geographic Information Council, been endorsed by the 

FGDC and the NGAC, and involves a heavy investment from the U.S. Department of Agriculture. The approximate 3-year total cost for this activity is $140 

million, equally split between the Departments of the Interior and Agriculture. 

For fiscal year 2010, we urge the subcommittee to provide $23.4 million for Agriculture’s component. 

—A GIS-based Recovery.Gov.—President Obama has insisted that Stimulus 

spending be subject to maximum transparency and accountability, enabling citizens to understand how their funds are being spent and how their communities 

will be affected. Recovery.gov, the web-based tool being launched by OMB for 

this purpose, must provide complete, understandable, authoritative and actionable information and analysis to elected and appointed officials, and to ordinary 

citizens. We propose that Recovery.gov be equipped with interactive maps and 

geospatial analytic tools that will substantially improve understanding and effectiveness of Recovery Act execution. An interactive map provides an intuitive 

foundation to understand, integrate, and interrogate this disparate and overwhelming amount of information, and to support better and timelier analysis 

and decisions. The application of GIS technology would allow public users to access and view Recovery Act spending patterns against established goals and underlying local and national conditions. In this way, it will allow the public to 

evaluate whether the government is making the right choices on where money 

is spent, and whether spending is yielding the right results. The approximate 

3-year total cost for this activity is $250 million across the Departments of the 

Interior ($100 million), Agriculture ($50 million), Commerce ($50 million), and 

Homeland Security ($50 million). For fiscal year 2010, we urge the subcommittee to provide $16.7 million for Agriculture’s component. 

—Parcel Data.—Based on the National Academies of Science, National Research 

Council (NRC) recent report ‘‘National Land Parcel Data: A Vision for the Future,’’ the land parcel data layer (also known as cadastral data) is used by governments to make decisions on land development, business activities, regulatory 

compliance, emergency response, and law enforcement. The NRC report con-
150 

cludes that nationally-integrated land parcel data is necessary, feasible, and affordable. Development of a national land parcel system would also provide an 

invaluable analytical tool to help manage the mortgage crisis. The NGAC endorsed the recommendations in the NRC report in October. The approximate 3- 

year total cost for this activity is $200 million for the Department of the Interior. 

—Elevation.—Today, high density digital elevation models are produced by a technology called LiDAR and IfSAR, an aerial mapping technology that provides 

highly accurate mapping of ground elevations. FEMA currently uses LiDAR 

data for flood mapping whenever such data are available. LiDAR data are also 

being utilized extensively in natural resource management, and new uses are 

being demonstrated for emergency response and homeland security purposes. 

An investment in a national Elevation initiative would produce consistent elevation dataset encompassing the entire country. The approximate 3-year total 

cost for this activity is $300 million, equally split between the Department of 

the Interior and the National Oceanic and Atmospheric Administration. 

—Wildlife Corridor/Crucial Habitat.—The pressure for rapid economic development and increased energy production threatens our natural resources. The 

Western Governors’ Association has recommended a Wildlife Corridor and Crucial Habitat Decision Support System. This system will support informed decisions on community growth, alternative energy expansion, biodiversity preservation, and resolving water resource issues. This effort will produce a consistent 

nationwide wildlife map and GIS management system. The approximate 3-year 

total cost for this activity is $110 million for the Department of the Interior. 

Conclusion 

The key step is to get it done now. America’s financial crisis today, the worst since 

the end of World War II, will force difficult actions and decisions. Large expenditures of taxpayer money must be designed to yield products of long-term benefit to 

the country. America has an information economy, and a robust geospatial infrastructure (system of digital maps and tools) is just as vital to its continued development as was the physical infrastructure to the industrial economy. A National GIS, 

properly designed and effectively implemented, providing public access and using 

best technologies, will speed economic recovery by producing jobs and putting shovels in the ground more quickly. It will also leave the country with a public utility, 

a modern geospatial information system, that itself can become a foundation for new 

generations of industries and technologies in the future. 

PREPARED STATEMENT OF FLORIDA STATE UNIVERSITY

Florida State University is requesting $5,000,000 in fiscal year 2010 for the Risk 

Reduction for Agricultural Crops Program from the Cooperative State Research 

Education and Extension Service/Research and Education Activities/Federal Admin. 

Account. 

Mr. Chairman, I would like to thank you and the Members of the Subcommittee 

for this opportunity to present testimony before this Committee. I would like to take 

a moment to briefly acquaint you with Florida State University. 

Located in Tallahassee, Florida’s capitol, FSU is a comprehensive Research university with a rapidly growing research base. The University serves as a center for 

advanced graduate and professional studies, exemplary research, and top-quality 

undergraduate programs. Faculty members at FSU maintain a strong commitment 

to quality in teaching, to performance of research and creative activities, and have 

a strong commitment to public service. Among the current or former faculty are numerous recipients of national and international honors including Nobel laureates, 

Pulitzer Prize winners, and several members of the National Academy of Sciences. 

Our scientists and engineers do excellent research, have strong interdisciplinary interests, and often work closely with industrial partners in the commercialization of 

the results of their research. Florida State University had over $200 million this 

past year in sponsored research awards. 

Florida State University attracts students from every State in the Nation and 

more than 100 foreign countries. The University is committed to high admission 

standards that ensure quality in its student body, which currently includes National 

Merit and National Achievement Scholars, Rhodes and Goldwater Scholars, as well 

as students with superior creative talent. Since 2005, FSU students have won more 

than 30 nationally competitive scholarships and fellowships including 3 Rhodes 

Scholarships, 2 Truman Scholarships, Goldwater, and 18 Fulbright Fellowships. 
151 

At Florida State University, we are very proud of our successes as well as our 

emerging reputation as one of the Nation’s top public research universities. 

Mr. Chairman, let me summarize our primary interest today. The current drought 

in the southeastern USA, the worst in recent history, has had significant impacts 

on the water resources. It has reemphasized the vulnerability of the citizens to climate variability and climate extremes. The Federal Government can reduce these 

risks by using modern technologies such as climate models, which can predict future 

climate, and decision support tools to help mitigate some of these uncertainties and 

provide adaptation strategies for the agricultural and environmental sectors. The 

Southeast Climate Consortium (SECC), which includes Florida State University, the 

University of Florida, the University of Miami, the University of Georgia, Auburn 

University, the University of Alabama at Huntsville, North Carolina State University and Clemson University, has been at the forefront of research and extension 

for the application of climate predictions to risk reduction for agriculture and natural resources. With support from USDA and NOAA, the SECC has developed new 

methods to predict the consequences of climate variability for agricultural crops, forests, and water resources in the southeastern USA. In recent real-life tests, these 

methods have been applied to the problems that farmers raising specialty crops face 

arising from variable rainfall, temperature, and wild fires. This program has strong 

support of extension in all States. The new tasks that can be accomplished with the 

funds requested are to develop improved methods to forecast droughts and other extreme climate events. These forecasts will be incorporated into decision support systems to help agricultural, forest, and natural resource managers to reduce risks of 

losses and environmental damage. The SECC will develop new partnerships and 

methods for incorporating climate forecasts into agricultural and water policy decisions and will continue the development of a decision support system to provide seasonal and multi-year projections to water resources managers, especially for agricultural water use. Lastly, the SECC will initiate research to determine risks and appropriate agricultural responses to longer term trends in climate. We are requesting 

$5,000,000 for this project. 

Mr. Chairman, this project will have a great impact on our country and I appreciate your consideration. 

PREPARED STATEMENT OF FRIENDS OF AGRICULTURAL RESEARCH—BELTSVILLE, INC. 

Mr. Chairman, and Members of the Subcommittee, thank you for this opportunity 

to present our statement regarding funding for the Department of Agriculture’s Agricultural Research Service (ARS), and especially for the Agency’s flagship research 

facility, the Henry A. Wallace Beltsville Agricultural Research Center (BARC), in 

Maryland. Our organization—Friends of Agricultural Research—Beltsville—promotes the Center’s current and long-term agricultural research, outreach, and educational missions. 

Before going to the heart of our testimony, please allow us to note for the record 

that during fiscal year 2010 the Beltsville Agricultural Research Center will mark 

a great historical milestone, a milestone to celebrate the many great and small accomplishments that BARC research has contributed to the Nation’s agricultural 

bounty and to the overall march of scientific progress. A full century will have 

passed since 1910, the year research in Beltsville began with the assembly of a 

dairy cattle herd for research purposes. The ensuing BARC story is by all rights a 

national story—a story of world-class accomplishment. BARC Director Joseph 

Spence and his staff are planning a series of worthy events to commemorate the 

centennial year. 

The Friends of Agricultural Research-Beltsville (FAR–B) is honored to be both a 

participant in the centennial planning process and a contributor to coming events. 

We would be pleased, Mr. Chairman, to answer any questions, to collect any information or citations the Subcommittee might wish regarding the centennial or our 

testimony. 

We now turn to the specifics of our testimony for fiscal year 2010: 

Under-Funded Salary Growth.—$1,700,000 

First, we appreciate the restoration of items that were recommended for termination in the president’s proposed budget for fiscal year 2009. We would hope that 

the fiscal year 2010 budget does not identify additional program terminations at 

BARC, and we would hope that there will be much needed funding increases. In the 

fiscal year 2009 budget, there was only about half of the needed funding for salary 

increases that went into effect at the beginning of the year. An unfortunate result 

of recent annual increases in Federal salaries—without offsetting funding in-
152 

creases—is a negative growth in funding available for discretionary spending on research. This situation has continued for several years now, and it has had a significant negative impact on ARS research. 

FAR–B strongly recommends funding adjustments to offset the almost yearly decline of net research funding resulting from under-funded salary increases. 

Research Initiatives 

While it is unclear at this time if the fiscal year 2010 budget includes funding 

for additional research at BARC, it is important to point out that BARC conducts 

many areas of research and that the research is of the highest national priority. 

BARC research presents many compelling opportunities to reward agriculture, the 

environment, and the consumer. 

Food Safety—$500,000.—The Beltsville Area recently established the largest single food safety unit in ARS. This research unit will focus on a number of issues, 

including safety of fruits and vegetables and food safety issues related to organic 

agriculture. The ability exists at BARC to raise crops and animals under farm conditions, and then to process, store, and package the resulting products. A unique 

feature of the food safety research program at BARC is the ability to propose and 

test interventions that greatly reduce pathogen exposure in foods, and ultimately in 

people. 

Genomic Prediction—$1,500,000.—The promise of understanding the genome of 

plants and animals is being fully exploited at Beltsville. In groundbreaking research 

conducted here, scientists have been able to quickly and accurately identify dairy 

bulls that will produce daughters capable of producing the most milk. Now a simple 

test at birth can predict at twice the accuracy and at a cost of about $250 the potential of a bull to sire high producing cows. Traditionally, bull prediction methods 

have required farmers to obtain production records of 50 to 100 daughters per bull 

to determine his genetic merit, at a cost up to $50,000 per bull. The potential for 

developing and expanding this breakout technology is huge and at great savings to 

dairy farmers and consumers alike. 

Climate Change—$1,500,000.—BARC has truly unique growth chambers that can 

measure and observe plant growth at every stage from root to stem, and under 

every conceivable atmospheric condition. BARC is using these chambers to measure 

the effects of increasing atmospheric CO2 and changes in environmental temperatures. Studies are underway not only on agronomically important crops, but also on 

invasive weeds. Research shows that environmental changes may enhance the rapid 

growth of invasive plants, thus threatening to exacerbate already costly problems 

for American agriculture. 

Obesity Prevention—$500,000.—Obesity negatively impacts the health and productivity of the American public. Moreover, obesity comes with greatly increased risk 

of chronic diseases that dramatically add to the economic costs of health care. The 

Beltsville Human Nutrition Research Center (BHNRC) is researching barriers and 

facilitators to help the American public follow Federal dietary guidelines. A major 

research emphasis is to prevent obesity through a better understanding of why people make the food choices they do. This research also will help USDA design and 

implement more effective food assistance programs. 

Waste Utilization—$1,000,000.—Because it is a working farm and has research 

scientists who have expertise in animal science, conversion technologies, and environmental science, BARC is an ideal place to study the utilization of farm-generated 

waste products. Farm-generated waste products can be environmentally harmful, 

have little or no value to the farmer, and disposal can be costly. Work at Beltsville 

has led to the effective development of technologies and products that take waste 

by-products and convert them to valuable new products. Examples include biofuels 

and plastics made without petroleum. 

Trade Enhancement and Global Competitiveness—$2,000,000.—BARC maintains 

and expands the Federal Government’s unique collections of materials and organisms that are of utmost importance in identifying pests and for ensuring that unwanted pests are prevented from entering the United States and producing destruction of animals and plants of economic importance. These unique and irreplaceable 

collections include the Germplasm Resource Information Network, and invaluable 

reference collections of insects, nematodes, parasites, and fungi. These world-class 

collections attract leading experts from around the world who study and use them 

for their own purposes. The collections are absolutely critical to identifying and preventing exotic pest problems from entering the United States through imports or by 

international travelers as well as demonstrating that our exports are safe. The continued availability of research in this general area of systematics is essential for 

trade, for homeland security, and for the protection of American agriculture. 
153 

Chesapeake Bay Improvement—$500,000.—BARC scientists are working with 

farmers on Maryland’s Eastern Shore to learn how to improve on-farm conservation 

practices that will improve water quality in the Chesapeake Bay. The research 

goals—targeting the entire range of Eastern Shore farming practices—include reducing fertilizer and pesticide usage. A central goal is to create agronomic and animal waste management practices that will reduce fertilizer usage and control pollution runoff. Biocontrol studies are searching out ways to minimize the need for pesticides. Scientists also are using advanced remote sensing and hydrological technologies to protect the health of the Chesapeake watershed. 

FAR–B strongly recommends continued funding for these high-value, critically 

needed research initiatives. 

Facilities.—$30 Million 

Ongoing facility needs at BARC are a reflection of the age of many of the buildings and infrastructure at BARC. As the program and the number of employees has 

decreased over time due to lack of funding, the burden of maintaining a large research facility has taken its toll in terms of routine and ongoing maintenance. It 

is essential that additional funding be provided for general facility maintenance and 

that plans for facility consolidation move forward. 

With talk of greatly increased expenditures of the Federal Government for facilities projects that are ‘‘shovel-ready’’, it is our hope that the Beltsville Area will be 

the recipient of a significant amount of those funds. Several projects at BARC are 

fully designed and ready for construction to begin almost immediately. These include the final phase of construction of the Beltsville Human Nutrition Research 

Center (BHNRC), in which existing building 307 will be gutted and rebuilt. This 

will allow BARC to relocate the entire BHNRC-now spread out at three separate 

locations—to one location and also free up space for other needed research activities. 

The completion of this important building renovation is urgently needed at BARC 

because many of the proposed space consolidations, which will greatly reduce the 

operating costs at the Center, are dependent on this project. 

Other projects that are fully designed and ready to go include three projects at 

the U.S. National Arboretum (USNA). The relocation of the USNA entrances from 

R Street and New York Avenue to Bladensburg Road is a major project that needs 

to move forward and will greatly improve public access while relieving traffic congestion on New York Avenue. Finally, the trash abatement project for the cleanup 

of Hickey Run needs to move forward. Rain runoff produces a great volume of trash 

as the result of inadequate storm water control by the District of Columbia. This 

trash accumulates on the property of the USNA. This project is urgently needed to 

prevent trash from washing onto the arboretum grounds, which now occurs with almost any significant rainfall. This project is also critically importance environmentally and for helping clean up the Anacostia River. The project has been completely designed and, while funds have been appropriated to the D.C. government 

and to ARS for this project, funding is not adequate to start construction on this 

project. 

FAR–B strongly recommends funding to complete these long delayed, urgently 

needed facility improvements. 

Mr. Chairman, that concludes our statement. We again thank you for the opportunity to present our testimony and for your interest and support. 

PREPARED STATEMENT OF THE IZAAK WALTON LEAGUE OF AMERICA

The Izaak Walton League of America appreciates the opportunity to submit testimony concerning appropriations for fiscal year 2010 for various agencies and programs under the jurisdiction of the Subcommittee. The League is a national, nonprofit organization founded in 1922. We have more than 36,000 members and nearly 

300 chapters and state divisions nationwide. Our members are committed to advancing common sense policies that safeguard wildlife and habitat, support community-based conservation, and address pressing environmental issues. The League 

has been a partner with farmers and a participant in forming agriculture policy 

since the 1930s. The following pertains to conservation programs administered by 

the U.S. Department of Agriculture. 

The Food, Conservation, and Energy Act (FCEA) of 2008 was enacted with a 

prominent commitment to increased mandatory conservation spending. We urge the 

Subcommittee to maintain the mandatory spending levels for conservation programs 

as provided in the act. The fiscal year 2010 budget is important to carrying out the 

changes in the 2008 bill and implementing new initiatives. These conservation programs are critical to working with farmers, ranchers and forest landowners to un-
154 

1 Redlin, Gupta, and Wiegand. 2007. The 2007 Farm Bill: Stewardship, Prosperity, and Fairness. Izaak Walton League of America. http://www.iwla.org/publications/agriculture/ 

FarmlBilll2007lWEB.pdf. 

dertake or improve conservation practices. These programs benefit producers 

through improved soil quality and productivity of their land, and the broader community through cleaner air and water and healthy habitat. 

Previous Farm Bills have included increased conservation authorizations that the 

League supported and fought hard to achieve. That pattern was certainly repeated 

with the new law, which contains a $25 billion investment in conservation programs 

overall. Although the authorization is important, the country will only realize the 

true benefit of conservation policies if appropriations match the authorized levels. 

As documented in our research on prior Farm Bill funding: 1

‘‘Congress has also cut the funding committed to conservation programs in the previous [2002] Farm Bill. More than $5 billion promised to conservation has been 

withheld. This despite the fact that as many as three-fourths of the eligible farmers 

and ranchers seeking conservation programs are turned away due to lack of funds. 

No similar caps have been applied to the unlimited crop payment programs.’’ 

We are disappointed that the President’s budget continues the unfortunate pattern of cutting conservation programs below mandatory levels established in the 

Farm Bill. The League is especially concerned about proposed cuts to the Wetland 

Reserve Program and Wildlife Habitat Incentives Program. Demand for participation in both far outstrips available funding, and this proposal will only exacerbate 

that problem as well as undermine conservation on-the-ground. It is critical that authorized levels for vital programs are met and maintained in fiscal year 2010 and 

all subsequent budget cycles for the life of the legislation. Specifically, the League 

believes achieving the following mandatory levels is essential: —Meeting the Wetland Reserve Program’s full 3.041 million acre, $1.2 billion allo- cation over the life of FCEA will require $473 million in fiscal year 2010 according to the Congressional Budget Office (CBO) March 2009 baseline. The President has proposed only $391 million and reduced the program acreage by 

139,000 acres. 

—Adding 1.22 million acres to the Grassland Reserve Program by 2012, scored at $300 million for the life of FCEA, with a CBO baseline of $78 million for 

fiscal year 2010. The Administration believes $54 million will fully fund the 

Farm Bill authorization for fiscal year 2010. 

—Maintaining the 32 million acre enrollment in the Conservation Reserve Pro- gram, scored at $9.8 billion over the life of FCEA, and $1.944 billion for fiscal 

year 2010. The Administration’s budget proposes full funding for CRP. —Achieving $85 million annually for the Wildlife Habitat Incentives Program. 

The budget proposed by the President cuts the program by more than half in 

fiscal year 2010 to $42 million. 

Additionally, the League worked to expand the Conservation Stewardship Program. Accompanying the positive revisions to better focus the program on higher environmental standards was an increase in authorized funding to support enrollment 

of approximately 13 million acres per year. The March 2009 CBO baseline places 

fiscal year 2010 mandatory funding at $752 million. The Office of Management and 

Budget (OMB) has scored funding full authorization at $681 million. With the numerous environmental challenges facing U.S. agriculture, including climate change, 

soil quality deficiencies, declining pollinator health, and huge water quality and 

quantity issues, we strongly urge the Subcommittee to provide the full baseline 

amount in its bill. 

Furthermore, effective implementation of Farm Bill conservation programs depends upon adequate technical resources to work with landowners in addressing 

their unique environmental concerns. Although conservation programs are available, 

under-investment in technical assistance limits agency support to assist farmers 

and ranchers in selecting and optimizing appropriate programs for their operations. 

Resource concerns and conservation practices vary throughout the country, and the 

technical assistance provided to program participants is necessary to address specific environmental concerns. The technical expertise of the Natural Resource Conservation Service and partners that assist in the delivery of programs and technical 

assistance directly to landowners is necessary for the adoption and maintenance of 

conservation practices. We request that the subcommittee support the mandatory 

levels of conservation program funding as provided in FCEA to enable robust technical resources to implement those programs successfully. 

Finally, the Sustainable Agriculture Research and Education (SARE) program is 

a very successful competitive grant program that funds farmer-driven research, edu-
155 

cation, and extension initiatives. SARE projects, and its unique regional approach, 

have a long record of building economic prosperity, innovation and opportunity in 

rural America—all integrally aligned with natural resource conservation. 

Demand for SARE is growing, however, most years it has been able to fund less 

than 10 percent of the proposals submitted. Forty million dollars are authorized for 

SARE’s research and education program and $20 million for its extension education 

and professional development program. However, appropriations for both programs 

have never topped $19 million. The League requests a minimum fiscal year 2010 

appropriation for SARE of $30 million, with $25 million allocated to research and 

education and $5 million to extension and professional development. 

We appreciate the opportunity to testify in strong support of fully-funding agricultural conservation programs. 

PREPARED STATEMENT OF GOODWILL INDUSTRIES INTERNATIONAL

Dear Chair and Ranking Member: On Behalf of Goodwill Industries International 

(Goodwill) and its 160 local Goodwill agencies in the United States, I wanted to 

thank you for your inclusion of funding in the American Recovery and Reinvestment 

Act targeted to low income workers and people with disabilities struggling in the 

midst of the recession. 

I am writing today to urge you to provide adequate funding in fiscal year 2010 

for a critical program that supports local Goodwill agencies’ efforts to help your constituents through the dignity of work. Especially during such trying economic times, 

Goodwill understands the difficult challenge that appropriators face as they struggle 

to stretch limited resources to support an ever-increasing list of national priorities. 

We stand committed to working with you toward implementing solutions that will 

restore economic stability by empowering disadvantaged populations 

While our agencies utilize a variety of Federal funding streams, AgrAbility is one 

of our highest priority programs. 

Goodwill has a long history in meeting the employment and training needs of people with disabilities who live and work in rural communities, including agriculture 

workers who have suffered disabling injuries. Agriculture consistently ranks as one 

of the nation’s most dangerous occupations. Each year, 90,000 agricultural workers 

sustain disabling injuries in work-related accidents. AgrAbility is a small $5 million program that consists of one National AgrAbility 

Project and more than 20 State/Regional AgrAbility Projects. These projects must 

involve a collaborative partnership between a land-grant university and one or more 

nonprofit organizations. 

State AgrAbility projects provide free on-farm consultations during which they assess abilities and needs, make recommendations for farm site or task modifications 

and assistive technology, then develop an action plan that allows program participants to continue to lead successful careers in production agriculture and farming 

or in another chosen field. In addition, the National AgrAbility Project (lead by Purdue University in partnership with Goodwill Industries International) provides technical assistance and professional training for State AgrAbility Projects, produces resource materials, and disseminates information related to the project. This project 

is the cornerstone of Goodwill’s efforts with rural communities. 

GOODWILL urges Congress to provide adequate funding for full implementation 

of AgrAbility Programs in all 50 States thereby ensuring that assistance is available 

in all 50 States to farmers, ranchers, other agricultural workers, and family members impacted by disability. 

Thanks for considering this request. Should you have questions, please feel free 

to contact Seth Turner, Director of Government Affairs and Public Policy, at 

seth.turner@goodwill.org or (240) 333–5508. 

PREPARED STATEMENT OF THE MINOR CROP FARMER ALLIANCE

The Minor Crop Farmer Alliance is an alliance of national and regional organizations and individuals representing growers, shippers, packers, handlers, and processors of various agricultural commodities, including food, fiber, nursery, and horticultural products, and organizations involved with public health pesticides. Our 

members are extremely interested in the development of pest management tools and 

techniques that are environmentally sound. While our commodities are often called 

‘‘minor crops,’’ they are vitally important components in the diets (fruits and vegetables) of all Americans and they contribute to safe and aesthetic surroundings for our 

homes, schools and places of business (turf, ornamental and nursery crops). Specialty crop agriculture in the United States is valued at more than $55 billion annu-
156 

ally and accounts for more than 20 percent of the value of agricultural products 

grown in this country. 

We request that $8.4 million be provided to the National Agricultural Statistical 

Service (NASS) in fiscal year 2010 specifically for the continuation of agricultural 

chemical use surveys for fruits, vegetables, floriculture and nursery crops. 

The U.S. Department of Agriculture’s (USDA) National Agricultural Statistics 

Service (NASS) discontinued its Chemical Use Surveys for these commodities and 

has stated that it needs $8.4 million in funding to continue the survey program. 

The chemical usage surveys are the only source of publicly available data on agricultural pesticide and fertilizer use. The surveys are used by the USDA Office of 

Pest Management Policy and the U.S. Environmental Protection Agency (EPA) to 

conduct risk assessments and make pesticide policy decisions. Farmers, commodity 

organizations and the public utilize the data to monitor pesticide and fertilizer use 

and it is essential data for use in public policy discussions and participation in rulemaking. 

Proprietary data are available to verify NASS data in EPA risk assessments, but 

it cannot be used as the sole source of data because EPA cannot share the data with 

the public without violating the terms of its proprietary purchasing agreement. This 

proprietary data is not always gathered using appropriate sampling schemes, leaving gaps in the information even for specialty crops that are widely grown. 

EPA relies on the NASS surveys to conduct pesticide risk assessments. Without 

the NASS survey data, EPA plans to default to 100 percent crop treated in future 

risk assessments. This could result in the cancellation of important crop protection 

tools for farmers. EPA has contacted USDA to communicate its strong support for 

the survey program. 

The Congress included language in the fiscal year 2009 Omnibus Bill that provided $2,450,000 to carry out the ‘‘Fruit Chemical Use Data Study.’’ While we welcome these additional funds for NASS, we hope that in fiscal year 2010 the Congress will provide the full amount needed to continue all of these critical surveys 

for fruits, vegetables, nursery and floricultural crops. 

Your consideration of this request is appreciated. 

American Farm Bureau Federation 

American Nursery & Landscape 

Association 

California Specialty Crops Council 

California Almond Board 

California Avocado Commission 

California Citrus Quality Council 

California Fig Advisory Board 

California Grape & Tree Fruit League 

California Processed Onion and Garlic 

Research Committee 

California Dried Plum Board 

California Strawberry Commission 

California Tree Fruit Agreement 

Cherry Marketing Institute, Inc. 

Cranberry Institute 

Del Monte Foods 

Florida Citrus Mutual 

Florida Fruit & Vegetable Association 

Florida Tomato Exchange 

Food Products Association 

Idaho Potato Commission 

Michigan State Horticultural Society 

Michigan Vegetable Council Inc. 

National Council of Farmer Cooperatives 

National Onion Association 

National Potato Council 

North Central Washington Fieldman’s 

Association 

Northwest Horticultural Council 

Produce Marketing Association 

Society of American Florists 

United Fresh Produce Association 

USA Dry Pea and Lentil Council, Inc. 

U.S. Apple Association 

U.S. Hop Industry Plant Protection 

Committee 

Washington Association of Wine and 

Grape Growers 

Washington Hops Commission 

Washington State Potato Commission 

Western Growers Association 

Western Pistachio Association 

Wild Blueberry Commission of Maine 

PREPARED STATEMENT OF THE NATIONAL COALITION FOR FOOD AND AGRICULTURAL

RESEARCH

Dear Chairman Kohl and Ranking Member Brownback: The National Coalition 

for Food and Agricultural Research (National C–FAR) urges the Subcommittee and 

Committee to increase Federal investment in food and agricultural research, extension and education (RE&E) as a critical component of Federal appropriations for fiscal year 2010, including at least $300 million for the new Agriculture and Food Research Initiative (AFRI). 

President Obama has acknowledged the need for a major investment in research, 

saying at the annual meeting of the National Academy of Sciences that the United 

States will ‘‘devote more than 3 percent of our GDP to research and development.’’ 
157 

We support President Obama’s goal, and advise you that food and agriculture research must be a part of his vision. 

The potential payoff is enormous for both Americans’ health and the nation’s economy. Federal investments in food and agricultural RE&E have brought profitability 

to production agriculture, found solutions for difficult conservation and environmental challenges, addressed the many issues of food safety, and provided the baseline for our whole knowledge of human nutrition. 

Now, RE&E must seek solutions for feeding growing populations, dealing with climate change, developing sustainable fuel production, maintaining ecosystem health, 

and assuring all people food security and proper nutrition. Now is the time to grow 

investment in our nation’s agricultural research enterprise and build on the successes of the past by increasing funding for a variety of food and agricultural research, extension and education efforts, and in particular the new National Institute 

of Food and Agriculture (NIFA) and AFRI. 

National C–FAR urges the Subcommittee to increase funding for AFRI to at least $300 million in fiscal year 2010 with a goal of funding AFRI at the fully authorized 

level as soon as practicable, and by fiscal year 2013 at the latest. AFRI, the successor to USDA’s National Research Initiative (NRI) and the Initiative for Future 

Agriculture and Food Systems (IFAFS), is an integrated approach that takes research and innovation beyond the development phase, into implementation through 

contemporary education and extension programs. National C–FAR opposes taking 

funds from other RE&E programs in USDA to fund AFRI. 

NIFA, AFRI and other recent reforms offer a new opportunity to transform 

USDA’s RE&E mission. AFRI will support research on key problems of national and 

regional importance in biological, environmental, physical, and social sciences relevant to agriculture, food, and the environment on a peer-reviewed, competitive 

basis. Additionally, AFRI should enable USDA to continue leveraging a portion of 

its RE&E funds fostering the development of partnerships with other Federal agencies that advance agricultural science. 

National C–FAR also supports the administration’s fiscal year 2010 requests for 

other parts of USDA’s RE&E mission, including: the remainder of the Cooperative 

State, Research, Education and Extension Service (CSREES) beyond AFRI, the Agricultural Research Service (ARS), Economic Research Service (ERS) and Forest 

Service (FS). 

The Research Title of the Farm Bill represents the nation’s signature Federal investment in the future of the food and agricultural sector. Other Farm Bill titles 

depend heavily upon the Research Title for tools to help achieve their stated objectives. Public investment in food and agricultural research, extension and education 

today and in the future must simultaneously satisfy needs for food quality and 

quantity, resource preservation, producer profitability and social acceptability. 

Tools provided through RE&E are needed to help achieve safer, more nutritious, 

convenient and affordable foods delivered to sustain a well nourished, healthy population; more efficient and environmentally friendly food, fiber and forest production; 

improved water quality, land conservation, wildlife and other environmental conditions; less dependence on non-renewable sources of energy; expanded global markets 

and improved balance of trade; and more jobs and sustainable rural economic development. Societal demands and expectations placed upon the food and agricultural 

system are ever-changing and growing. 

Multiple examples, such as those highlighted below, serve to illustrate current 

and future needs that arguably merit enhanced public investment in research, extension and education so that the food and agricultural system can respond to these 

challenges on a sustainable basis: 

—Strengthened bio-security is a pressing national priority. There is a compelling 

need for improved biosecurity and bio-safety tools and policies to protect against 

bio-terrorism and dreaded problems such as foot-and-mouth and ‘‘mad cow’’ diseases and other exotic plant and animal pests, and protection of range lands 

from invasive species. 

—Food-linked health costs are high. Some $100 billion of annual U.S. health costs 

are linked to poor diets, obesity, food borne pathogens and allergens. Opportunities exist to create healthier diets through improvements in the food supply and 

in consumer knowledge and implementation of dietary guidance. 

—Research, extension and education are key to providing to solutions to environment and conservation challenges related to global warming, limited water resources, enhanced wildlife habitat, and competing demands for land and other 

agricultural resources. Rural water conservation and development of droughtresistant crops have evolved from a good idea to a necessity. 

—It is a highly competitive world for food and agriculture and rural America. 

There was considerable debate during the last Farm Bill reauthorization about 
158 

how expanded food and agricultural research, extension and education could enhance farm income and rural revitalization by improving competitiveness and 

value-added opportunities. 

—Energy costs are escalating, dependence on petroleum imports is growing and 

concerns about greenhouse gases are rising. Research, extension and education 

can enhance agriculture’s ability to provide renewable sources of energy and 

cleaner burning fuels, sequester carbon, and provide other environmental benefits to help address these challenges, and indeed generate value-added income 

for producers and stimulate rural economic development. 

—Population and income growth are expanding the world demand for food and 

natural fiber and improved diets. World food demand is projected to double in 

25 years. Most of this growth will occur in the developing nations where yields 

are low, land is scarce, and diets are inadequate. Without a vigorous response, 

demand will only be met at a great global ecological cost. 

—Regardless of one’s views about biotechnology and genetic resources, an effective 

publicly funded research role is needed for oversight and to ensure public benefits. 

Publicly financed RE&E is a necessary complement to private sector research, focusing in areas where the private sector does not have an incentive to invest, when 

(1) the pay-off is over a long term; (2) the potential market is more speculative; (3) 

the effort is during the pre-technology stage; and (4) where the benefits are widely 

diffused. Public research, extension and education help provide oversight and measure long-term progress. Public research, extension and education also act as a 

means to detect and resolve problems in an early stage, thus saving American taxpayer dollars in remedial and corrective actions. 

The USDA, ERS September 2007 Economic Brief titled, ‘‘Economic Returns of 

Public Agricultural Research,’’ shows the average social rate of return to public investment in agricultural research is nearly 50 percent. However, Federal funding 

for food and agricultural research, extension and education has been essentially flat 

for over 20 years, while support for other Federal research has increased substantially. Public funding of agricultural research in the rest of the world during the 

same time period has outpaced investment in the United States, leading to competitive concerns. There also are vast areas where the public will trust only U.S. Federal investments in research—a case in point is human nutrition research. 

By any measure, Federal funding for food and agricultural research, extension 

and education—which has declined about one-fourth since fiscal year 2003—has 

failed to keep pace with identified priority needs. Allowing this decline to continue 

is likely to irrevocably harm our responses to human needs and competitive forces. 

It is imperative to lay the groundwork now to respond to the many challenges and 

promising opportunities ahead through Federal policies and programs needed to promote the long-term health and vitality of food and agriculture for the benefit of both 

consumers and producers. Stronger public investment in food and agricultural 

RE&E is essential in producing research outcomes needed to help deliver beneficial 

and timely solutions on a sustainable basis. 

National C–FAR serves as a forum and a unified voice in support of sustaining 

and increasing public investment at the national level in food and agricultural research, extension and education. National C–FAR is a nonprofit, nonpartisan, consensus-based and customer-led coalition established in 2001 that brings food, agriculture, nutrition, conservation and natural resource organizations together with 

the food and agriculture research and extension community. 

We agree with President Obama that, ‘‘Science is more essential for our prosperity, our security, our health, our environment, and our quality of life than it has 

ever been.’’ 

PREPARED STATEMENT OF NATIONAL COALITION FOR FOOD AND AGRICULTURAL

RESEARCH

Dear Chairman Kohl and Ranking Member Brownback: The undersigned organizations and individuals urge the Subcommittee and Committee to increase funding 

for the new Agriculture and Food Research Initiative (AFRI) to at least $300 million 

in fiscal year 2010 (exclusive of any funding identified for the former Section 406 

programs) as a first step toward funding AFRI at the fully authorized level of $700 

million annually. AFRI, the successor to USDA’s National Research Initiative (NRI) 

and the Initiative for Future Agriculture and Food Systems (IFAFS), is an integrated approach that takes research and innovation beyond the development phase, 

into implementation through contemporary education and extension programs. 
159 

The Food, Conservation, and Energy Act of 2008 established the Agriculture and 

Food Research Initiative (AFRI), a new competitive grants program authorized at 

$700 million annually, for research, extension, and education in support of our Nation’s food and agricultural systems within USDA’s National Institute of Food and 

Agriculture. 

We support full funding of AFRI at the authorized level of $700 million annually, 

and urge the Subcommittee to fully fund AFRI as soon as practicable, by fiscal year 

2013 at the latest. This is consistent with President Obama’s commitment to return 

our Nation to sound science. With the Nation and world seeking solutions for climate change, sustainable fuel production, ecosystem health, food security and nutrition challenges, now is the time to grow investment in our Nation’s food and agricultural research. 

Thank you for your leadership action in investing in America’s food and agriculture system. 

American Dietetic Association 

American Feed Industry Association 

American Malting Barley Association 

American Phytopathological Society 

American Society for Nutrition 

American Soybean Association 

American Veterinary Medical 

Association (AVMA) 

Aquatic Plant Management Society 

(APMS) 

Association of American Veterinary 

Medical Colleges 

Biotechnology Industry Organization 

Council for Agricultural Science and 

Technology 

Donald Danforth Plant Science Center 

Institute of Food Technologists 

National Association of Wheat Growers 

National Barley Growers Association 

National Barley Improvement 

Committee 

National Coalition for Food and 

Agricultural Research 

National Farmers Union 

National Oat Improvement Committee 

National Sunflower Association 

National Wheat Improvement 

Committee 

North American Millers’ Association 

North Central Weed Science Society 

(NCWSS) 

Northeastern Weed Science Society 

(NEWSS) 

Southern Weed Science Society (SWSS) 

Dr. Steven G. Pueppke, National 

Agricultural Biotechnology Council 

The Council on Food, Agricultural and 

Resource Economics (C–FARE) 

The Peanut Foundation 

Professor Robert L. Thompson, Gardner 

Endowed Chair in Agricultural Policy 

Agricultural & Consumer Economics 

Dept., University of Illinois 

U.S. Canola Association 

USA Dry Pea & Lentil Council 

Weed Science Society of America (WSSA) 

Western Society of Weed Science 

(WSWS) 

PREPARED STATEMENT OF THE NATIONAL COMMODITY SUPPLEMENTAL FOOD

PROGRAM ASSOCIATION

Mr. Chairman and Subcommittee Members, thank you for this opportunity to 

present information regarding the USDA/FNS Commodity Supplemental Food Program (CSFP). 

The National Commodity Supplemental Food Program Association (NCSFPA) requests the Senate Agriculture Appropriations Subcommittee fund CSFP for fiscal 

year 2010 at $203 million and include language directing the Department to utilize 

all available resources to supplement the CSFP food package and meet the rising 

demand for nutritional assistance among our vulnerable senior population. 

This first effort at national food assistance began in 1969 with monthly packages 

designed to supplement protein, calcium, iron, vitamins A and C for low-income 

mothers and children (preceding WIC); nutrients shown to be lacking in the diets 

of low-income households. Low-income seniors added in 1983 now comprise 93 percent of all CSFP participants. 

CSFP is a unique program that brings together federal and state agencies, along 

with public and private entities, The USDA purchases specific nutrient-rich foods 

at wholesale prices. State agencies providing oversight, contract with community 

and faith based organizations to warehouse and distribute food, certify eligibility 

and educate participants. The local organizations build broad collaboration among 

non-profits, health units, and area agencies on aging for simple, fast access to the 

supplemental foods (canned fruits and vegetables, juices, meats, fish, peanut butter, 

cereals, grain products, cheese and dairy products from American farmers) and nutrition education to improve their health and quality of life. This partnership 

reaches even homebound seniors in both rural and urban settings with vital nutri-
160 

tion and remains an important ‘‘market’’ for commodities supported under various 

farm programs. 

In fiscal year 2008, the CSFP provided services through 150 non-profit community 

and faith-based organizations at 1,800 sites located in 32 States, the District of Columbia, and two Indian Tribal Organizations (Red Lake, Minnesota and Oglala 

Sioux, South Dakota). On behalf of those organizations NCSFPA would like to express our gratitude for the increased fiscal year 2009 funding. However, we are disappointed that the increase in funding did not result in more seniors receiving food. 

CSFP’s 40 years of service is a testimony to the power of community partnerships 

of faith-based organizations, farmers, private industry and government agencies. 

The CSFP offers a unique combination of advantages unparalleled by any other food 

assistance program: 

—The CSFP specifically targets our Nation’s most nutritionally vulnerable populations: young children and low-income seniors—many of whom will not qualify 

for other nutrition assistance programs. 

—The CSFP provides a monthly selection of food packages tailored to specific nutritional needs. Eligible participants are guaranteed [by law] a certain level of 

nutritional assistance, nutrition education, and food preparation guidance each 

month. 

—The CSFP purchases foods at wholesale prices, directly supporting American 

farmers. The average food package cost is estimated at $23.01 and the retail 

value is $50.00–$60.00. 

—The CSFP involves the entire community. Thousands of volunteers and private 

companies donate money, equipment, and most importantly time and effort to 

deliver food to needy and homebound seniors. These volunteers not only bring 

food but companionship and other assistance to seniors who might have limited 

support systems. (See Attachment 1) 

In a recent CSFP survey, more than half of seniors living alone reported an income of less than $750 per month. One-half of respondents from two-person households reported an income under $1,000 per month. 25 percent were enrolled in the 

Supplemental Nutrition Assistance Program (SNAP) and 50 percent said they ran 

out of food during the month. 70 percent of senior respondents said they choose between medicine and food. 

The Senate Agriculture Appropriations Subcommittee has consistently supported 

CSFP, acknowledging it as a cost-effective way of providing nutritious supplemental 

foods. Last year this subcommittee and all of Congress provided funding for CSFP 

in direct opposition to its proposed elimination. Your support is again needed to provide adequate resources for the 473,473 mothers, children and seniors current participants; 37,500 low-income participants waiting in six new States, and 110,374 

seniors waiting in current states for this vital nutrition program. 

CSFP and other nutrition programs such as SNAP, are only supplemental programs by design. Together they cover a shortfall that many seniors face each month. 

These programs must have support to meet the increasing need as part of the ‘‘safety net’’. 

‘‘The Managers fully support continued operation of this program and recognize 

the need for a substantial expansion of CSFP. the Managers encourage the Secretary to approve all remaining states for expansion and to expand caseload in all 

participating states.’’ Joint Statement of Managers, H.R. 2419, the Food, Conservation and Energy Act of 2008. 

‘‘CSFP has charms worth considering in designing human service programs the 

program’s trademarks were its simplicity and accessibility . . . CSFP in particular 

represents a guaranteed source of high quality food, delivered in a balanced package.’’ The Role of CSFP in Nutritional Assistance to Mothers, Infants, Children and 

Seniors. The Urban Institute, August 2008. 

The National Commodity Supplemental Food Program Association requests the 

following: 

To continue serving the 473,473 needy seniors (93 percent of participants), 

women, infants and children (7 percent of participants) currently enrolled in 

CSFP—$164 Million. 

To meet USDA’s commodity procurement expenses—$0.8 Million. 

To respond to the needs of 37,500 eligible seniors in the 6 States with USDA approved plans: Arkansas (5,000), Delaware (2,500), Oklahoma (5,000), New Jersey 

(5,000), Utah (3,000) and Georgia (10,000)—$9.3 Million. 

To meet the increased demand/need of an additional 110,374 at risk seniors in 32 

States per requests turned into USDA by current CSF programs nationwide—$28.6 

Million. 
161 

Appropriation needed to maximize this program’s effectiveness in serving 621,347 

seniors, women, infants and young children challenged by hunger and malnutrition 

in our Nation—$203 Million. 

A 1997 report by the National Policy and Resource Center on Nutrition and Aging 

at Florida International University, Miami—Elder Insecurities: Poverty, Hunger, 

and Malnutrition indicated that malnourished elderly patients experience 2 to 20 

times more medical complications, have up to 100 percent longer hospital stays, and 

incur hospital costs $2,000 to $10,000 higher per stay. Proper nutrition promotes 

health, treats chronic disease, decreases hospital length of stay and saves health 

care dollars. America is aging. CSFP must be an integral part of Senior Nutrition 

Policy and plans to support the productivity, health, independence and quality of 

life for America’s seniors, many of whom now need to continue working at least 

part-time beyond retirement age to afford basics. 

The National CSFP Association recommends the following: 

—Support and expand the program in those states that have a need and interest 

in the CSFP, including the 6 States that already have USDA-approved plans 

to operate CSFP (Arkansas, Delaware, New Jersey, Oklahoma, Utah and Georgia) and states demonstrating a willingness to expand current CSFP services 

to meet rising demand. 

— Provide language encouraging the U.S. Department of Agriculture to utilize all 

available resources to meet the rising demand for this nutritional support. 

—The CSFP is committed grassroots operators and dedicated volunteers with a 

mission to provide quality nutrition assistance economically, efficiently, and responsibly always keeping the needs and dignity of our participants first. We 

commend the Food Distribution Division of Food and Nutrition Service of the 

Department of Agriculture for their continued innovations to strengthen the 

quality of the food package and streamline administration. 
162 

FISCAL YEAR 2008 NATIONAL CSFP ASSOCIATION ADMINISTRATIVE EXPENSE/VALUE SURVEY 

Programs USDA Reim- bursed Cash Not Reimbursed by USDA Cash CSFP Expendi- tures Cash Goods & Services donated to agen- cy Value Volunteer Labor Hours Value Annual Total Pro- gram Value Percent Paid by USDA Extra Goods do- nated to CSFP participants 

New Hampshire ....................................................................................... $461,361 ........................ $461,361 ........................ $61,121 $522,482 88 $16,097 New York ................................................................................................. 1,947,032 $2,500,000 4,447,032 $20,700 3,984 4,471,716 44 6,500 Vermont FB .............................................................................................. 233,132 ........................ 233,132 ........................ ........................ 233,132 100 ........................Washington, DC ....................................................................................... 434,945 1,600,000 2,034,945 800,000 173,632 3,008,577 14 ........................Pennsylvania ........................................................................................... 912,209 18,637 930,846 32,169 48,259 1,011,274 90 100,000 Kentucky .................................................................................................. 980,911 64,645 1,045,556 ........................ 24,577 1,070,133 92 624,093 Mississippi .............................................................................................. 437,969 ........................ 437,969 30,520 199,906 668,395 66 7,104 North Carolina ......................................................................................... 75,126 ........................ 75,126 ........................ ........................ 75,126 100 ........................South Carolina ........................................................................................ 232,192 ........................ 232,192 ........................ 1,342 233,534 99 22,500 Tennessee 1 ............................................................................................. 840,812 ........................ 840,812 ........................ ........................ 840,812 100 ........................Illinois ...................................................................................................... 869,405 ........................ 869,405 ........................ 25,643 895,048 97 ........................Indiana .................................................................................................... 269,732 25,000 294,732 25,000 68,502 388,234 69 32,189 Michigan .................................................................................................. 4,861,625 314,317 5,175,942 310,168 1,722,543 7,208,653 67 4,637,316 Minnesota ................................................................................................ 881,829 319,848 1,201,677 2,213 449,733 1,653,623 53 864,844 Red Lake, MN 1 ....................................................................................... 6,204 ........................ 6,204 ........................ ........................ 6,204 100 ........................Ohio ......................................................................................................... 978,890 198,896 1,177,786 65,770 328,264 1,571,820 62 85,774 Wisconsin ................................................................................................ 316,547 50,000 366,547 ........................ 275,406 641,953 49 54,610 Louisiana ................................................................................................. 4,089,578 ........................ 4,089,578 330,000 1,104,420 5,523,998 74 ........................New Mexico .............................................................................................. 1,032,128 129,911 1,162,039 248,791 233,955 1,644,785 63 479,843 Texas ....................................................................................................... 997,895 157,200 1,155,095 ........................ 297,774 1,452,869 69 ........................Colorado .................................................................................................. 1,104,198 67,533 1,171,731 57,449 119,319 1,348,499 82 1,343,961 Iowa ......................................................................................................... 216,086 353,367 569,453 ........................ 13,463 582,916 37 ........................Kansas ..................................................................................................... 328,548 7,200 335,748 10,000 83,642 429,390 77 89,519 Missouri ................................................................................................... 583,040 ........................ 583,040 ........................ 16,608 599,648 97 ........................Montana 1 ................................................................................................ 425,091 ........................ 425,091 ........................ ........................ 425,091 100 ........................Nebraska ................................................................................................. 820,898 75,529 896,427 40,470 301,447 1,238,344 66 70,479 North Dakota 1 ......................................................................................... 175,413 ........................ 175,413 ........................ ........................ 175,413 100 ........................South Dakota ........................................................................................... 176,228 8,416 184,644 ........................ 26,464 211,108 83 ........................Ogala Sioux, SD 1 .................................................................................... 40,360 ........................ 40,360 ........................ ........................ 40,360 100 ........................Alaska ...................................................................................................... 134,803 63,000 197,803 1,015,000 104,235 1,317,038 10 ........................Arizona ..................................................................................................... 940,739 252,000 1,192,739 2,000 184,312 1,379,051 68 2,000,000 California ................................................................................................. 3,373,339 580,027 3,953,366 35,400 1,248,232 5,236,998 64 379,140 Nevada .................................................................................................... 371,461 174,278 545,739 ........................ 24,960 570,699 65 179,400 Oregon ..................................................................................................... 84,166 96,573 180,739 4,436 44,317 229,492 37 5,200 
163 

Washington .............................................................................................. 228,871 7,500 236,371 208,000 90,076 534,447 43 ........................

Grand Total ................................................................................ 29,862,763 7,063,877 36,926,640 3,238,086 7,276,137 47,440,863 63 11,306,319 

1 No information provided Feb. 24, 2009 Client Extras incl.: flu shots, fresh produce, clothing, books, toys, health screenings, personal care items, energy efficient items, dairy, baked goods, eye exams, etc. 
164 

PREPARED STATEMENT OF THE NATIONAL COOPERATIVE BUSINESS ASSOCIATION

The National Cooperative Business Association, which represents all types of cooperatives, appreciates the opportunity to submit testimony on the request for a 

funding level of $8.25 million for the Rural Cooperative Development Grant (RCDG) 

program in the Rural Development Agency of the U.S. Department of Agriculture. 

This request includes funds to work in areas of high national priority including 

helping to create worker owned enterprises, e.g., worker ownership succession of existing rural businesses; health care; renewable energy and energy efficiency; and affordable housing. 

Background.—The RCDG program is a competitive grants program, administered 

by USDA’s Rural Development, Rural Business—Cooperative Services Program. 

RCDG provides matching grant funding to nonprofits or institutions of higher education that operate cooperative development centers primarily serving farmers and 

groups seeking to form cooperatively owned businesses in rural areas. 

Cooperative development centers use the grants to fund critical technical assistance for economic development, such as legal and accounting assistance, feasibility 

studies, business planning, board education, and other services that help ensure the 

success of these businesses. The centers have helped start or expand more than 400 

cooperative businesses that have created over 5,800 new rural jobs in virtually every 

sector of the economy. Investment in these cooperatives exceeds $900 million. 

President Obama recognized the critical nature of the RCDG program in his budget outline. He included rural cooperative development grants among the five Rural 

Development programs needed ‘‘to spur the development of small business and 

value-added agriculture in rural America.’’ 

The program, begun in 1993, is authorized at $50 million, but has never been appropriated at more than $6.5 annually despite the demand and cost effectiveness 

of the program. USDA typically receives 40–50 applications for funding annually, 

but historically has only been able to fund 20–25 centers. In fiscal year 2008, approximately $4.6 million was available for RCDG grants, with a maximum grant 

award of $200,000 per center. Another $500,000 was appropriated in this section for 

research on the impact of cooperative businesses, and $1.2 million for grants to minority-owned cooperatives, for a total appropriation of approximately $6.4 million. 

This program leverages a small amount of funding into much larger amounts 

while it promotes ownership and entrepreneurship. While the program requires a 

25 percent match, centers have been leveraging dollar for dollar this funding with 

non-federal funding sources. The RCDG program is the only dedicated source of federal funding supporting the cooperative development centers. 

The Need for Assistance From Centers.—The Centers play a critical role in identifying and assisting new businesses to gain access to public funding, especially 

USDA loan and grant programs. Congress recognized the need when it developed 

the program and stated that ‘‘the Committee hopes to link cooperatives from different communities and different sectors of the economy to strengthen the cooperative 

movement as a whole.’’ (emphasis added) Federal Agriculture Improvement and Reform Act of 1996, Conf.Rep., p. 432. 

One of the ways Congress tried ‘‘to strengthen the cooperative movement as a 

whole’’ with the program was to ‘‘emphasiz[e] job creation in rural areas through 

the development of rural cooperatives, value added processing, and rural businesses.’’ (Conf.Rep., p. 431). 

At a time when rural America is in desperate need of jobs, the centers are wellsituated to assist in an efficient and effective disbursement of economic stimulus 

and other funds to rural areas in need. But in order to do this, Congress needs to 

increase the maximum grant for centers back closer to historic levels. Under current 

funding, the maximum grant request for RCDG has been reduced from $300,000 in 

fiscal year 2005 to $200,000 currently, resulting in a significant reduction in support 

for core center operations, compounded by the effect of inflation. To bring funding 

up to an adequate level, we urge this subcommittee to provide $8.25 million for the 

RCDG program in this year’s appropriations bill. 

The Fiscal Year 2010 Request.—The request this year is for $8.25 million, which 

includes the following: 

—$4.6 million for general rural cooperative development grants to centers proposing to work in any area of rural cooperative development; 

—$2.0 million to be awarded to those successful RCDG applicants who have both 

a demonstrated track record and that propose to conduct rural cooperative development in the following areas of high national priority: creation of worker 

owned enterprises, including worker or community ownership succession of existing rural businesses; health care; renewable energy and energy efficiency, 

and affordable housing. Such applicants may request up to $75,000 in supple-
165 

mental grant awards to fund work in these areas of national priority. Funds not 

used for these purposes may be used by USDA to fund additional RCDG grants. 

—$450,000 for research on the economic impact of all types of cooperatives. 

—$1.2 million for grants to minority-owned cooperatives. 

This request would allow USDA to competitively award $200,000 each to approximately 23–25 centers. Of these awardees, centers with both a track record and a 

proposal to work in one or more of the specified areas of national priority would be 

able to request an additional $75,000, for a total award of $275,000. Funding for 

minority-owned cooperatives would be funded at the same level, and funding for research would be reduced by $50,000 from fiscal year 2008 levels. 

Addressing High Priority Rural Economic Needs.—This request addresses high 

priority needs by providing increased support for work in areas that are critical to 

retaining and creating employment, improving health care, creating affordable housing, and reducing dependence on fossil fuels. Successful cooperative solutions have 

been demonstrated in each of these critical areas in various places throughout the 

country. Technical assistance is required to replicate and broadly extend those successful models. 

Rural America is populated with a number of profitable companies where rural 

jobs are at risk of loss due to a failure of succession planning, where aging or retiring owners do not have heirs that are interested or capable of taking over the business. Transfer to employee or community ownership is a good option in these cases, 

as these jobs then are retained in communities instead of being outsourced to urban 

or foreign buyers. But there must be business assistance infrastructure available before the owner is ready to retire or the business closes. Cooperative development 

centers can provide this assistance. 

Health care delivery is a major issue affecting rural areas, where most of America’s aging population resides. Demonstrated opportunities for cooperative development include worker-owned home health care cooperatives, purchasing or shared 

services cooperatives for rural hospitals, and others. Harvard’s Kennedy School of 

Government highlighted worker-owned home health care businesses as an award 

winning solution to providing jobs and benefits to rural workers while increasing the 

quality of care that allow aging rural residents to stay in their homes. 

Creation of affordable rural housing is an on-going need, made even more urgent 

by the nation’s housing and foreclosure crisis. Substantial cooperative successes 

have been achieved by the conversion of manufactured home parks on rented lots 

to resident-owned communities. These co-ops have stabilized the availability of 

housing, and created greater long-term security for residents. 

Successful cooperative development can also be seen in response to both the need 

for renewable energy production (such as through ethanol and biodiesel cooperatives), and through consumer-owned energy cooperatives aimed at energy conservation and efficiency. 

The 2008 farm bill made changes to the program including allowing the award 

of grants on a multi-year basis and a provision for USDA to conduct ongoing research on the economic impact of cooperatives. The changes are designed to make 

more effective and efficient use of the ongoing capacity and expertise developed by 

co-op development centers around the country. 

Ongoing Research on Cooperatives.—The request includes $450,000 for a cooperative research agreement between USDA and a qualified academic institution to continue research on the national economic impact of cooperatives. The research money 

is needed to continue tracking information on the number, type and economic impact of cooperatives across America and to assess the effectiveness of the RCDG program. 

In April, the first results of the federally supported research on the economic impact of cooperatives were released, showing significant contribution of the co-op sector to the U.S. economy—73,000 firms own more than $3 trillion in assets, generate 

over $650 billion in revenues and pay more than $75 billion in wages for 2 million 

jobs. 

While these results are a start, the 2008 farm bill requires USDA to conduct ongoing research on the economic impact of all types of cooperatives. This research can 

be used to track performance of cooperatives, how much capital is recycled into local 

economies, the success of Federal funds targeted at cooperative development, and 

determining other economic as well as social benefits of cooperatives. The fiscal year 

2010 RCDG appropriation should include funding for this critical research. 

Funding History.—The program has received funding since 1993. Previous funding levels (including RCDG grant funding, research funding, and grant funding to 

minority-owned co-ops): Fiscal year 2009 $6.18 million; fiscal year 2008 $6.423 mil-
166 

1 $900,000 that was appropriated to program for fiscal year 2007 in the Continuing Resolution 

was taken out of program to fund another program. 

lion; fiscal year 2007 $6.4 million; 1 fiscal year 2006 $6.4 million; fiscal year 2005 $6 million; fiscal year 2004 $6.5 million; fiscal year 2003 $6.5 million; fiscal year 

2002 $5.25 million; fiscal year 2001 $4.5 million; fiscal year 2000 $4 million; fiscal 

year 1999 $1.75 million; fiscal year 1998 $1.7 million; fiscal year 1997 $1.7 million; 

fiscal year 1996 $1.33 million; fiscal year 1995 $1 million; fiscal year 1994 $750,000; 

and fiscal year 1993 $700,000. 

Conclusion.—We appreciate this opportunity to provide information about the re- quest for $8.25 million for the Rural Cooperative Development Grant Program. We 

urge the Subcommittee to support the request. 

PREPARED STATEMENT OF THE NATIONAL COTTON COUNCIL

The National Cotton Council welcomes the opportunity to provide the following 

recommendations and requests for fiscal year 2010 appropriations funding for selected programs under the jurisdiction of the subcommittee which make important 

contributions to our industry’s ability to compete and prosper in a world market. We are requesting $23.39 million for APHIS for the Joint Cotton Pests Account 

and sufficient funding to continue the Farm Service Agency’s authority to make up 

to $100 million in loans to eligible Foundations to be used in conducting activities 

related to the boll weevil and pink bollworm eradication programs. The industry requests an additional $700,000 above current funding ($1.54 million) be made available to ARS to be used to add a research position at the ARS Gin Lab located at 

Lubbock, TX. Adequate cost-share funding and loan authority to facilitate the successful completion of the boll weevil and the pink bollworm eradication programs; 

continued development of new technology through research; sufficient financial resources, personnel and computer equipment for FSA and FAS to successfully carryout their respective missions; and, funding for demand building export programs including MAP, FMD and GSM export credit guarantees are all essential to the cotton 

industry. The National Cotton Council also strongly supports the provisions of the 

2008 farm law. 

The National Cotton Council of America (NCC) is the central organization of the 

U.S. cotton industry representing growers, ginners, warehousemen, cottonseed interests, merchants, cooperatives and manufacturers whose primary business operations 

are located in 18 cotton producing States. Cotton Council International (CCI) is the 

overseas promotion arm of the cotton industry. NCC represents producers who cultivate between 10 and 14 million acres of cotton. Annual cotton production averaging approximately 20 million 480-lb bales is valued at more than $5 billion at the 

farm gate. While a majority of the industry is concentrated in the 18 cotton-producing States, the down-stream manufacturers of cotton apparel and home-furnishings are located in virtually every State. The industry and its suppliers, together with the cotton product manufacturers, account for more than 230,000 jobs 

in the United States. In addition to the cotton fiber, cottonseed products are used 

for livestock feed, and cottonseed oil is used for food products ranging from margarine to salad dressing. Taken collectively, the annual economic activity generated 

by cotton and its products in the U.S. economy is estimated to be in excess of $120 

billion. 

FUNDING PRIORITIES

Joint Cotton Pests (APHIS).—The National Cotton Council requests $23.39 million 

for APHIS to provide a Federal Cost Share for Boll Weevil Eradication and Pink 

Bollworm Eradication programs which were combined in fiscal year 2008 into a joint 

cotton pest account. As these programs near completion, the cost share funding for 

APHIS is even more critical to insure the complete eradication of these cotton pests 

for the benefit of those in post eradication maintenance areas. Additional details for 

the Boll Weevil Eradication Program and the Pink Bollworm Eradication Program 

are provided below as separate programs. 

Boll Weevil Eradication (APHIS—Cotton Pests).—The National Cotton Council requests $15.1 million for APHIS to provide a Federal cost share of approximately 30 

percent to active boll weevil eradication programs underway in Texas. Cotton in the 

active eradication zones of Texas will require program activity in 2010 to continue 

progress toward full eradication. A large portion of this area is in habitats favorable 

to the boll weevil, primarily in the Southeast third of the State. For example, in 

central and south Texas, the boll weevil is especially adapted to the milder winter 

temperatures, longer growing seasons, and more humid summertime conditions. The 
167 

lack of ‘‘killing frost’’ permits escape cotton plants (plants growing in non-cotton 

field habitats like ditch, fence row, etc.) to thrive year long, thus providing a source 

for sustained life and reproduction of boll weevils. Extra efforts have been employed 

to locate and remove these escape plants. Additionally, several zones in Texas have 

encountered significant costs because of weevils migrating out of the zones with 

high weevil populations into adjacent zones with near eradication levels of weevils. 

Studies have indicated this movement has been enhanced by hurricane winds. Even 

with these significant challenges, progress toward full eradication continues to be 

made. 

The program continues to produce documented economic and environmental benefits. Cotton in the United States was produced in 2007 with an average of only 2.78 

sprays per acre for all insects. This compares to 15 to 20 applications per acre prior 

to adoption of Bt cotton for worm control and implementation of boll weevil eradication. 

Nationally, USDA estimates that 94 percent of the U.S. cotton acreage is now free 

of boll weevils. Additionally, Mexico continues eradication programs in cotton areas 

along the U.S./Mexico border. 

Adequate Federal cost-share funds are critical to timely completion, especially 

since eradication is within sight. APHIS should be directed to make every effort to 

minimize overhead and administrative expenses for boll weevil eradication to ensure 

maximum funding reaches field operations. 

The fiscal year 2010 boll weevil request is less than fiscal year 2009 and continues 

the annual reduction in keeping with our commitment to reduce Federal cost-share 

funding as the program moves toward completion. 

Boll Weevil Eradication (FSA).—The National Cotton Council requests sufficient funding to allow FSA to make at least $100 million in loans to eligible Boll Weevil 

Eradication Foundations. The Council also strongly supports providing FSA with 

continued authority to make loans for activities associated with the pink bollworm 

eradication program as previously provided in the fiscal year 2005 appropriations 

legislation. 

Pink Bollworm Programs (APHIS—Cotton Pests).—The National Cotton Council 

requests $8.29 million for the APHIS pink bollworm program. This will provide 

$2.14 million for indirect and direct costs to APHIS and the residual $6.15 million 

‘‘Net to Field’’ will be for program operations. The Pink Bollworm Eradication Program originally was planned for a three phase expansion over several years. Insufficient funding resulted in Phase III being divided into Phase III(a) and Phase III(b) 

to allow partial expansion in fiscal year 2007. However, data revealed mass late season migration spilled into areas in eradication from outside eradication. Fiscal year 

2008 marked the first year to expand into the last remaining areas of infestation. 

The fiscal year 2010 request is less than the fiscal year 2009 request as a result 

of a reduction in sterile moth releases needed in some areas. 

The Pink Bollworm Eradication Program is based predominately on the mass release of sterile insects generated by a rearing facility located in Phoenix, AZ. Although this technique is favored over conventional insecticide spray application, the 

rearing costs include items related to fuel to maintain facility temperature most favorable to the insect and to soybean meal, a major diet ingredient. Soybean meal 

has almost doubled in cost (2007 vs. 2008). Insect rearing costs alone account for 

over $4 million of the budget. The shipping and mass release of these sterile insects 

via airplane over areas of California, Arizona, New Mexico, and Texas has increased 

due to fuel price increases. Costs have also greatly increased for the plastic raw material used to manufacture the trays that contain the insects during rearing. 

The Bi-National Pink bollworm eradication program has been implemented in 

three phases, with the final expansion started in 2008, to eliminate pink bollworm 

as a cotton pest in Texas, New Mexico, Arizona, California and adjacent cotton areas 

in Northern Mexico. It was expected that fiscal year 2009 would be the peak request 

for the program. Subsequent years are expected to require less support due to successful eradication in the earliest phases of the program. It is anticipated that fiscal 

year 2010 needs will meet that expectation. Mexico remains a partner in the eradication effort and continues to expand eradication programs along the border in conjunction with the United States. 

The funds requested for fiscal year 2010 will enable the Phoenix Pink Bollworm 

Rearing Facility to rear and release up to 20 million sterile pink bollworm moths 

per day to supply program needs. The Phoenix Pink Bollworm Rearing Facility 

(PBRF) is a partnership between the California growers and APHIS. The cost share 

for pink bollworm is essential to provide APHIS expertise and operational coordination in mass rearing and daily area-wide aerial releases of millions of moths. 

Market Access Program (MAP).—The National Cotton Council strongly supports 

funding levels authorized in 2008 farm law. Cotton Council International (CCI) ac-
168 

tively promotes exports of U.S. cotton and cotton products in Asia, Europe, Africa, 

and Central and South America. Activities carried out using MAP (and FMD) have 

been responsible for increased export sales of cotton fiber and value-added cotton 

products. The value of U.S. cotton fiber exports exceeds $4 billion, and exports of 

value-added cotton products contribute an additional $6 billion to the overall value 

of cotton exports. For every $1 in MAP and FMD funds, CCI has generated matching contributions of over $4.00. 

Foreign Agriculture Service (FAS).—The industry supports sufficient funding to 

ensure FAS is adequately staffed to carry out important market development and 

trade enhancing functions in headquarters and abroad. 

Foreign Market Development (FMD).—The FMD program is used to encourage and 

support U.S. commodity groups to undertake long-term market development and 

trade servicing. FMD is currently funded at $34.5 million and requires at least a 

dollar-for-dollar industry match. The industry requests that funding be continued at 

the same level as provided for fiscal year 2009. 

Farm Service Agency (FSA).—Provide adequate funding so the agency can continue to deliver essential farm and conservation programs and services. 

Agricultural Research Service (ARS).—The industry is concerned with current 

support provided to this agency. The agency has faced a flat budget for most of the 

recent past fiscal years since 2001 and when not flat, its budget has suffered cuts. 

We respectfully request that this agency be considered for increased overall funding 

to allow the valuable research conducted on behalf of all agriculture to continue at 

sustainable levels. We specifically urge the subcommittee to provide increased base 

funding for the following research facility: 

Lubbock, TX Cotton Production and Processing Research Unit (Ginning Lab) of the 

Cropping Systems Research Laboratory (ARS)—$2.27 million.—The request for 

$2.27 million in annual operating budget represents an increase of $700,000 from 

the funding levels provided in fiscal year 2008 and fiscal year 2009. This cotton ginning research facility is specifically equipped for research into the stripper harvested cotton production systems on the Texas High Plains, the largest contiguous 

production region in the United States. This unit is the only research unit within 

the ARS system that has a cotton harvesting research component of any type and 

while, historically, the unit’s focus has been on stripper harvesting, the region’s producers have in recent years been able to utilize new cultivars of upland cottons, 

adapted for their region, with vastly improved qualities that are best preserved if 

harvested by a machine picker rather than by a machine stripper. Research into 

best possible harvest alternatives is vital for this region’s production to take advantage of international market preferences for longer, stronger cotton fiber and provide 

for continued profit improvements for the growers of this region. 

Historically this unit has been staffed with four full time scientists (4-SY’s). In 

recent years, however, the lab has been operating with only 3-SY’s, with the harvest 

focused position vacant due to retirement. Currently, harvest research is being conducted by a talented post-doctoral fellow with supplemental funds provided by industry through a grant from Cotton Incorporated, which is necessary to cover his 

direct salary and support functions. While this is a much appreciated stop gap approach, it is imperative for the long term viability of the unit for a fourth full time 

scientist position to be restored with appropriate support. ARS administrators indicate that this requested funding level will support a fourth scientist, long term, as 

well as provide for the necessary indirect support necessary for a viable 4-SY unit. 

Also included in this request is funding of critical cotton ginning particulate matter emissions research impacting all production regions which is conducted at this 

location. The development of this first class particulate emissions laboratory has become a valuable resource for determining and characterizing particulate emissions 

for many agricultural operations in addition to cotton ginning. In addition, this laboratory cooperates in research to improve Grain Sorghum Cold Tolerance, thus improving production of this valuable feed grain on the High Plains. Grain Sorghum 

is an important ingredient in animal feeds and as a feedstock for ethanol production. 

All of these activities are in addition to the basic ginning research necessary for 

support of the Texas and Southwest Region’s cotton production industry. 

Thank you for your consideration of the cotton industry’s recommendations for 

funding for programs under the subcommittee’s jurisdiction for fiscal year 2010. 

PREPARED STATEMENT OF THE NATIONAL ENVIRONMENTAL SERVICE CENTER

Thank you for the opportunity to offer testimony to the Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies. 
169 

We request $1.5 million for the National Drinking Water Clearinghouse (NDWC), 

a program that provides water infrastructure services for small communities and 

rural areas nationwide. 

Introduction 

My name is Gerald Iwan. I serve as executive director of the National Environmental Services Center (NESC), located at West Virginia University in Morgantown, West Virginia. Previously, I was for 20 years the drinking water administrator for the State of Connecticut Department of Public Health, during which time 

I oversaw the implementation of all regulatory aspects of the Safe Drinking Water 

Act (SDWA). In my present assignment with NESC, I manage a unique program 

with nationally recognized expertise in drinking water, wastewater, and small community infrastructure security and emergency preparedness. NESC provides specialized technical assistance and training services and is an in-depth repository of information to small and rural communities nationwide. 

Water and Wastewater Infrastructure Challenges 

Approximately 42,000 small and rural communities across the country with populations of 3,300 or fewer people receive their drinking water from small, communityoperated water systems (EPA, 2009). These systems are mandated to comply with 

the Safe Drinking Water Act in providing reliable and safe water services. The system operators typically have limited financial, human and equipment resources. 

These systems account for the majority of SDWA violations. The USDA’s Water and 

Wastewater Grants and Loans program may be the only option small system operators have to obtain funding to address necessary system improvements. Organizations such as the NDWC can provide reliable technical assistance in advising the 

system operators and in helping them to overcome the many challenges they face 

in complying with local, State and Federal regulations. 

Recognizing these challenges, the USDA makes funds available through the 

‘‘Rural Water and Wastewater Technical Assistance and Training (RWTA) Programs’’ under authorization provided in the Consolidated Farm and Rural Development Act (the Farm Bill). The National Drinking Water Clearinghouse is one RWTA 

program. We have been funded by USDA for 18 years to help communities and rural 

areas identify and evaluate solutions to water or wastewater problems, improve facility operation and maintenance, and prepare funding applications for water or 

wastewater treatment facility construction projects. 

Deliverables Provided by the NDWC 

The NDWC serves local officials, utility managers, system operators and RWTA 

professionals in small and rural communities. Congressional support would enable 

us to provide the following deliverables to our stakeholders. Telephone callers would 

obtain toll-free drinking water technical assistance from our staff of certified operators, engineers, and scientists. Our quarterly publication ‘‘On Tap,’’ a magazine for 

small drinking water systems, provides information about water treatment, financing, and management options and would be distributed free of charge to 26,000 subscribers. A comprehensive Web site www.NESC.wvu.edu and databases with thousands of entries will be maintained to provide ‘‘round the clock’’ access to contemporary information for small water systems. Training sessions customized for small 

and rural areas, teleconferences, and more than 600 free and low-cost educational 

products would be provided to give people the instruction and tools they need to address their most pressing drinking water issues. Our staff of experts will be available to visit small communities, if invited, to offer in-the-field assessments and advice to the host communities. 

We anticipate an even greater need for NDWC services in 2010 due to the current 

recession and the federal effort to stimulate the economy through infrastructure 

projects. Stimulus funding in the water sector has been so far predominately directed to construction, with little or no funding directed to support water and wastewater facility operation and maintenance, or for technical assistance programs such 

as provided by the NDWC. Small and ruralcommunities will need increased support 

from units such as ours to plan for and protect their current and future utility assets. The NDWC has accordingly expanded its scope of deliverables for fiscal year 

2010 to provide additional services. It is imperative that the NDWC continues to 

receive funding from the Technical Assistance and Training Grants (TAT) account 

to assist small communities with their drinking water systems and associated concerns related to protecting drinking water supplies from contamination. 

Request 

In order to provide services to meet this national need, we request a congressionally directed appropriation of $1.5 million to continue and increase the NDWC pro-
170 

gram services through the Technical Assistance and Training (TAT) Grants account. 

Thank you for considering our request. 

PREPARED STATEMENT OF THE NATIONAL ORGANIC COALITION

My name is Steven Etka. I am submitting this testimony on behalf of the National Organic Coalition (NOC) to detail our requests for fiscal year 2010 funding 

for several USDA marketing, research, and conservation programs of importance to 

organic agriculture. 

The National Organic Coalition (NOC) is a national alliance of organizations 

working to provide a voice for farmers, ranchers, environmentalists, consumers, cooperative retailers and others involved in organic agriculture. The current members 

of NOC are the Beyond Pesticides, Center for Food Safety, Equal Exchange, Food 

and Water Watch, Maine Organic Farmers and Gardeners Association, Midwest Organic and Sustainable Education Service, National Cooperative Grocers Association, 

Northeast Organic Dairy Producers Alliance, Northeast Organic Farming Association-Interstate Policy Council, Rural Advancement Foundation International—USA, 

and the Union of Concerned Scientists. 

We urge the Subcommittee’s strong consideration of the following funding requests for various USDA programs of importance to organic farmers, marketers and 

consumers: 

USDA/Agricultural Marketing Service (AMS) 

National Organic Program—Request: $8 million 

In fiscal years 2006 and 2007, funding of $2.026 was appropriated for the National Organic Program within the AMS budget. For fiscal year 2008, in keeping 

with the President’s budget request for the program, $3.18 million was appropriated 

for the National Organic Program. The NOP appropriation grew again in fiscal year 

2009 to a funding level of $3.867 million. 

Sales of organic food and beverages continue to grow at an average rate of 20 percent per year in this country. While funding levels for USDA’s National Organic 

Program (NOP) have grown in recent years, the growth in resources for this regulatory agency has not kept pace with the market growth of the organic sector. 

For NOP to be a credible regulator and enforcer of the USDA organic label, resources must increase significantly, and long overdue policies must be established 

within NOP to ensure consistency in the standards, transparency in the standards 

setting process, and proper enforcement. If the funding for this program does not 

expand significantly to meet the growing needs, we fear that the important work 

of the NOP will suffer, the integrity of the organic standards will be jeopardized, 

and public confidence in the USDA organic label will be eroded. 

Specifically, the Members of the National Organic Coalition urge the Committee to funding the National Organic Program at $8 million for fiscal year 2010, as authorized by Section 10303 of the Food, Conservation, and Energy Act of 2008, and 

to include language directing NOP to undertake the following critical activities, as 

established by the Organic Foods Production Act (OFPA) of 1990. 

—Establish a Peer Review Panel, as called for in Section 2117 of the Organic 

Foods Production Act (OFPA) of 1990, and Section 205.509 of USDA’s own organic regulations; to provide oversight of USDA’s accreditation process for organic certifying agents. 

—Reinstate funding for independent, scientific reviews of substances proposed for 

use in organic agriculture, as required by OFPA. Historically, the National Organic Standards Board (NOSB) has had the benefit of independent scientific reviews, called Technical Advisory Panel (TAP) reviews, of any substance proposed for use in organic agriculture, to make sure that its use is compatible 

with the purposes of OFPA. However, in recent years, USDA has denied funding for these independent TAP reviews, leaving the NOSB with little information on which to base these important decisions. 

—Make the NOP budget fully transparent and accountable to the public, by publishing the details of the budget on the NOP website. 

—Finalize the pending pasture rule for organic livestock, and initiate rulemaking 

to address the issue of the origin of livestock. 

USDA 

Organic Data Initiatives 

Authorized by Section 7407 of the 2002 Farm Bill, the Organic Production and 

Marketing Data Initiative States that the ‘‘Secretary shall ensure that segregated 

data on the production and marketing of organic agricultural products is included 
171 

in the ongoing baseline of data collection regarding agricultural production and marketing.’’ Section 10302 of the Farm, Conservation, and Energy Act of 2008 amends 

the provision further to provide mandatory funding, and to provide further authorization for $5 million annually in discretionary funds for this effort. 

As the organic industry matures and grows at a rapid rate, the lack of national 

data for the production, pricing, and marketing of organic products has been an impediment to further development of the industry and to the effective functioning of 

many organic programs within USDA. The organic data collection and analysis effort at USDA has made significant strides in recent years, but remains in its infancy. Because of the multi-agency nature of data collection within USDA, organic 

data collection and analysis must also be undertaken by several different agencies 

within the Department: We are requesting the full $5 million to be appropriated for 

this initiative, to be divided between the three main data collection sub-agencies as 

follows: 

Economic Research Service (ERS).—Collection and Analysis of Organic Economic 

Data—Request: $1.5 million 

Agricultural Marketing Service (AMS).—Collection and Analysis of Organic Economic Data—Request: $3 million 

National Agricultural Statistic Service (NASS).—Organic Production Data—Request: $500,000 

USDA/CSREES 

Organic Transitions Program—Request: $5 million 

The Organic Transition Program, authorized by Section 406 of the Agricultural 

Research, Education and Extension Reform Act (AREERA) for Integrated Research 

Programs, is a research grant program that helps farmers surmount some of the 

challenges of organic production and marketing. As the organic industry grows, the 

demand for research on topics related to organic agriculture is experiencing significant growth as well. The benefits of this research are far-reaching, with broad applications to all sectors of U.S. agriculture, even beyond the organic sector. Yet funding 

for organic research is minuscule in relation to the relative economic importance of 

organic agriculture and marketing in this nation. Starting in fiscal year 2009, the 

program has been administered in combination with the CSREES Water Quality integrated research program, to study the watershed impacts of organic systems. 

The Organic Transition Program was funded at $2.1 million in fiscal year 2003, 

$1.9 million in fiscal year 2004, $1.88 million for both fiscal year 2005 and 2006, 

$1.855 million for fiscal year 2007 and 2008, and 1.842 million in fiscal year 2009. 

Given the rapid increase in demand for organic foods and other products, and the 

growing importance of organic agriculture, this important research program should 

be growing instead of contracting. Therefore, we are requesting that the program 

be funded at $5 million in fiscal year 2010. 

USDA/CSREES/Agriculture and Food Research Initiative (AFRI) 

Request: Report language on Conventional/Classical Plant and Animal Breeding 

In recent decades, public resources for classical plant and animal breeding have 

dwindled, while resources have shifted toward genomics and biotechnology, with a 

focus on a limited set of major crops and breeds. This problem has been particularly 

acute for organic and sustainable farmers, who seek access to germplasm well suited 

to their unique cropping systems and their local environment. 

Ever year since fiscal year 2005, the Senate Agriculture Appropriations Subcommittee has included report language raising concerns about this problem, and 

urging CSREES to give greater consideration to research needs related to classical 

plant and animal breeding, when setting priorities within the National Research 

Initiative. Despite this report language, research proposals for classical plant and 

animal breeding that have sought NRI funding in the recent years have been consistently declined. 

In Section 7406 of the Food, Conservation, and Energy Act of 2008, the National 

Research Initiative was merged with the Initiative for Future Agriculture and Food 

Systems to become the Agriculture and Food Research Initiative (AFRI). Congress 

included language within the AFRI to make ‘‘conventional’’ plant and animal breeding a priority for AFRI research grants, consistent with the concerns expressed by 

Appropriations Committee in the three preceding appropriations cycles. 

When CSREES released its AFRI Program Announcement in December of 2008, 

it invited research proposals on conventional/classical plant and animal breeding. 

However, when researchers submitted their initial letters of intent spelling out their 

research topics in the arena, they were nearly all rejected in the pre-proposal stage. 
172 

Therefore, we are requesting that report language be added to the CSREES/AFRI 

section of the report, stating the following: 

‘‘While the Committee is pleased that the new AFRI program language is now encouraging classical or conventional plant and animal breeding initiatives, we are 

concerned by the lack of progress in funding of actual projects in this research 

arena. The Committee urges USDA to make further progress by creating a clear, 

separate and on-going category of research funding for conventional/classical plant 

and animal breeding within AFRI, with adequate funding allocations to meet this 

critical and growing need.’’ 

USDA/CSREES 

Sustainable Agriculture Research and Education (SARE) Request: $25 Million 

(Research and Education Grants) and Education (SARE) and $5 Million 

(Professional Development Grants) 

The SARE program has been very successful in funding on-farm research on environmentally sound and profitable practices and systems, including organic production. The reliable information developed and distributed through SARE grants have 

been invaluable to organic farmers. For fiscal year 2010, we are requesting $25 million for research and education grants and $5 million for professional development 

grants. 

USDA/Rural Business Cooperative Service 

Appropriate Technology Transfer for Rural Areas (ATTRA)—Request: $3 million 

ATTRA, authorized by Section 6016 on the Food, Conservation, and Energy Act 

of 2008, is a national sustainable agriculture information service, which provides 

practical information and technical assistance to farmers, ranchers, Extension 

agents, educators and others interested and active in sustainable agriculture. 

ATTRA interacts with the public, not only through its call-in service and website, 

but also provides numerous excellent publications written to help address some of 

the most frequently asked questions of farmers and educators. Much of the realworld information provided by ATTRA is extremely helpful to both the conventional 

and organic communities, and is available nowhere else. As a result, the growth in 

demand for ATTRA services has increased significantly, both through the websitebased information services and through the growing requests for workshops. We are 

requesting $3 million for ATTRA for fiscal year 2010. 

USDA/ARS 

Organic Agricultural Systems Research—Request: Devote ‘‘Fair Share’’ of ARS 

Research Dollars, Commensurate With Organic’s Retail Market Share (Approximately $33 Million), to Direct Organic Research. 

USDA research programs have not kept pace with the growth of organic agriculture in the marketplace. Although organic currently represents nearly 4 percent 

of total U.S. food retail market, the share of USDA research targeted to organic agriculture and marketing is significantly less. With regard to ARS specifically, efforts 

have been made to devote greater resources to organic research. The current total 

funding for direct organic projects within ARS is about $14 million, about 1.5 percent of the ARS budget. Despite this progress, much more needs to be done in this 

area. We are requesting that a ‘‘fair share’’ of ARS expenditures (approximately $33 

million annually) be devoted to direct organic projects, using organic’s retail market 

share as a basis of comparison to the conventional sector. This should include the 

establishment of a clearinghouse for disseminating organic research information 

through the National Agricultural Library, Alternative Farming Systems Information Center (NAL–AFSIC). 

USDA/NRCS 

Conservation Stewardship Program—Request: No Funding Limitation 

USDA/Rural Business Cooperative Service 

Value-Added Producer Grants—Request: $40 million 

The Conservation Security Program (authorized by Section 2001 of the 2002 farm 

bill) and the Value-Added Producer Grant (authorized by Section 6401 of the 2002 

farm bill) have great potential to benefit organic and conventional producers in their 

efforts to conserve natural resources and to explore new, value-added enterprises as 

part of their operations. Unfortunately, while these programs were authorized to operate with mandatory funding, their usefulness has been limited by funding restric-
173 

tions imposed through the annual appropriations process. We are urging that the 

Conservation Security Program be permitted to operate with unrestricted mandatory funding, and that the Value-Added Producer Grant Program receive an appropriation of $40 million for fiscal year 2009. 

Food and Nutrition Service/WIC Program 

Report Language: Removing Barriers of Access to Organic Foods for WIC recipients 

Despite the scientifically documented nutritional and health benefits of organic 

food, particularly for pregnant mothers and small children, many States have greatly limited or prohibited access to organic foods as part of the WIC program. Some 

of the barriers are explicit, whereby WIC recipient are expressly prohibited in some 

States from using their WIC certificates or vouchers for organic versions of WIC 

foods. Others barriers are indirect, such as rules that make it difficult for retail 

stores that carry organic foods from participating in the program. Therefore, we are 

requesting that report language be included in the Food and Nutrition Service section of the fiscal year 2010 Appropriations report, such as: 

‘‘The Committee is concerned about the number of States the have set up barriers 

within the WIC program to hinder or prohibit WIC recipients from purchasing organic food. The Committee strongly urges FNS to actively encourage States to remove barriers to the purchase of organic foods as part of the basic food instrument, 

and to understand the nutritional and health benefits of organic foods for the vulnerable populations served by this program.’’ 

PREPARED STATEMENT OF THE NATIONAL POTATO COUNCIL

My name is Justin Dagen. I am a potato farmer from Karlstad, Minnesota and 

current Vice President, Legislative/Government Affairs for the National Potato 

Council (NPC). On behalf of the NPC, we thank you for your attention to the needs 

of our potato growers. 

The NPC is the only trade association representing commercial growers in 50 

States. Our growers produce both seed potatoes and potatoes for consumption in a 

variety of forms. Annual production is estimated at 437,888,000 cwt. with a farm 

value of $3.2 billion. Total value is substantially increased through processing. The 

potato crop clearly has a positive impact on the U.S. economy. 

The National Potato Council (NPC) urges the Congress to continue to fund programs critical to potato growers and to oppose any attempts to eliminate and/or curtail various critical research and other projects. For example, interruptions in 

CSREES funded projects will result in significant disruption or cancellation of valuable breeding research and the loss of varieties resulting from years of previous research. Much of this potato research is conducted jointly using potato industry and 

university funding. Similarly, ARS potato research is critical to the potato industry. 

The NPC’S fiscal year 2010 Appropriations Priorities are as follows: 

POTATO RESEARCH

Cooperative State Research Education and Extension Service (CSREES) 

The NPC urges the Congress not to support any attempt to eliminate the 

CSREES Special Grant Program for potatoes. This program supports and fine-tunes 

important university research work that helps our growers remain competitive in 

today’s domestic and world marketplace. 

The NPC supports an appropriation of $1,800,000 for the Special Potato Grant 

program for fiscal year 2010. The Congress appropriated $1,482,000 in fiscal year 

2006 and recommended the same amount in fiscal year 2007. However, the program 

only received $1,112,000 in fiscal year 2008 which was further reduced by the 

across-the-board cut and $1,037,000 in fiscal year 2009. This has been a highly successful program, and the number of funding requests from various potato-producing 

regions is increasing. 

The NPC also urges that the Congress include Committee report language as follows: 

‘‘Potato research.—The Committee expects the Department to ensure that funds 

provided to CSREES for potato research are utilized for varietal development testing. Further, these funds are to be awarded after review by the Potato Industry 

Working Group.’’ 
174 

AGRICULTURAL RESEARCH SERVICE (ARS)

The NPC urges that the Congress to continue the Congressional increases for research projects. 

The Congress provided funds for a number of important ARS projects and, due 

to previous direction by the Congress, the ARS continues to work with the NPC on 

how overall research funds can best be utilized for grower priorities. The NPC urges that $3 million per site be provided for the construction and/or 

the expansion of nematode research facilities at Cornell University in New York and 

in Idaho. The Potato Cyst Nematode Laboratory (PCNL) at Cornell University is 

structurally deficient and may lose its Federal license to operate as a quarantine 

facility. Its demise would put New York agriculture and the United States potato 

industries at risk. Equally important is the risk to the Western United States from 

the Idaho and Alberta outbreaks. A coordinated National Program is critical if export markets are to be maintained and this quarantined pest is to be contained. The 

Western facility could be constructed on University of Idaho land where an existing 

nematologist is present and a core ARS presence already exists. If PCN expands 

into other States, the entire U.S. potato industry will be affected, not only from direct damage by the pest (up to 80 percent yield loss), but more importantly, by embargoes disrupting interstate and international trade 

FOREIGN MARKET DEVELOPMENT

Market Access Program (MAP) 

The NPC also urges that the Congress maintain the spending level for the Market Access Program (MAP) at its authorized level of $200 million annually. 

Foreign Agriculture Service (FAS) 

The NPC supports a minimum of $279 million for salaries and expenses of the 

USDA Foreign Agriculture Service (FAS). This level is the minimum necessary for 

the Agency given the multitude of trade negotiations and discussions currently underway. The Agency has had to absorb pay cost increases, as well as higher operating costs for its overseas offices, such as increased payments to the Department 

of State for services provided at overseas posts. However, this minimal budget request does not allow for expanded enforcement activities to assure that various 

trade agreements are being properly implemented. The Congress should consider increasing the budget request to allow for more FAS trade enforcement activities. 

FOOD AID PROGRAMS

McGovern-Dole 

The NPC supports a level of at least $108 million for the McGovern-Dole International Food Aid Program. The Program has included potato products. 

PEST AND DISEASE MANAGEMENT

Animal and Plant Health Inspection Service (APHIS) 

Given the transfer of Agriculture Quarantine Inspection (AQI) personnel at U.S. 

ports to the Department of Homeland Security (DHS), it is important that certain 

USDA–APHIS programs be adequately funded to ensure progress on export petitions and protection of the U.S. potato growers from invasive, harmful pests and diseases. Even though DHS staffing has increased, agriculture priorities have not yet 

been adequately addressed. 

Golden Nematode Quarantine.—The NPC supports an appropriation of $1,266,000 

for this quarantine which is what is believed to be necessary for USDA and the 

State of New York to assure official control of this pest. Failure to do so could adversely impact potato exports. 

Emerging Plant Pests.—The NPC supports at least $145 million with $9.5 million 

going to the potato cyst nematode regulatory, control and survey activity. The recent 

discovery of Golden Nematode in seed fields in Alberta, and possibly linked to production fields in the United States, has increased the scope and cost of the national 

survey being conducted by USDA. In addition, the costs of the eradication program 

have increased due to rising input costs and some expansion of target acres. 

Pest Detection.—The NPC supports $45 million. This is essential for the Plant 

Protection and Quarantine Service’s (PPQ) efforts against potato pests and diseases, 

such as Ralstonia and the potato cyst nematode, and funds many cooperative pest 

and disease programs. 

Trade Issues Resolution Management.—The NPC supports $19 million but ONLY 

if any increase is specifically for plant protection and quarantine activities. These 

activities are of increased importance as new trade agreements are negotiated, the 
175 

Agency must have the necessary staff and technology to work on plant related import/export issues and to resolve phytosanitary trade issues in a timely manner. 

AGRICULTURAL STATISTICS

National Agricultural Statistics Service (NASS) 

The NPC supports an addition of $8.4 million and report language to assure that 

the potato objective yield and grade and size surveys and vegetable pesticide use 

surveys are continued. These surveys provide valuable data to the growers and the 

EPA for use in registration and reregistration decisions for key chemical tools. 

NASS has discontinued these chemical use surveys for fruits and vegetables. 

PREPARED STATEMENT OF THE NATIONAL FISH AND WILDLIFE FOUNDATION

Mr. Chairman and Members of the Subcommittee: Thank you for the opportunity 

to submit testimony regarding fiscal year 2010 funding for the National Fish and 

Wildlife Foundation (Foundation). We appreciate the Subcommittee’s past support 

and respectfully request your approval of $5 million through the Natural Resources 

Conservation Service’s (NRCS) Conservation Operations appropriation in fiscal year 

2010. This funding request is authorized and would allow the Foundation to expand 

our historical partnership with NRCS. 

In 2009, the Foundation is celebrating its 25th Anniversary and a remarkable history of bringing private partners together to leverage Federal funds to conserve fish, 

wildlife, plants and their habitats. 

The Foundation is required by law to match each federally-appropriated dollar 

with a minimum of one non-Federal dollar. We consistently exceed this requirement 

by leveraging Federal funds at a 3:1 ratio while providing thought leadership and 

emphasizing accountability, measurable results, and sustainable conservation outcomes. Funds appropriated by this subcommittee are fully dedicated to project 

grants and do not cover any overhead expenses of the Foundation. 

As of fiscal year 2008, the Foundation has awarded over 10,000 grants to more 

than 3,500 national and community-based organizations through successful partnerships with NRCS and other Federal agencies, including the USDA Forest Service, 

U.S. Fish and Wildlife Service and other Department of Interior agencies, Environmental Protection Agency, and National Oceanic and Atmospheric Administration. 

This effective model brings together multiple Federal agencies with State and local 

government and private organizations to implement conservation strategies on private lands that directly benefit diverse habitats and a wide range of fish and wildlife species. 

During fiscal year 2000–2006, the Foundation received an average appropriation of $3 million annually to further the mission of NRCS through a matching grant 

program focused on private lands conservation. Together, NRCS and the Foundation 

have supported nearly 500 grants to conservation districts, universities, Resource 

Conservation and Development Councils, and non-profit organizations who partner 

with farmers, ranchers, and foresters to support conservation efforts on private 

land. Through these efforts, the Foundation leveraged $21 million in NRCS funds 

into more than $85 million to conserve fish and wildlife habitat, reduce agricultural 

runoff, and remove invasive species in 50 States, the Caribbean, and the Pacific Islands. We ask that the subcommittee restore the NRCS appropriation for the Foundation in fiscal year 2010. 

This subcommittee’s support is critical to our success in attracting additional 

funding for agricultural conservation through corporate and foundation contributions, legal settlements, and direct gifts. As a neutral convener, the Foundation is 

in a unique position to work with the Federal agencies, State and local government, 

corporations, foundations, conservation organizations and others to build strategic 

partnerships to address the most significant threats to fish and wildlife populations 

and their habitats. Currently, the Foundation has active partnerships with more 

than 30 corporations and foundations and 17 Federal agencies. The Foundation is 

successfully building bridges between the government and private sector to benefit 

NRCS’s mission. Examples of those benefiting agricultural conservation include: —ArcelorMittal, the world’s largest steel company, established a $2.5 million partnership with the Foundation in 2008 to restore wildlife habitat in the Great 

Lakes. 

—The Kellogg Foundation contributed $750,000 of NRCS-matching funds through 

to support innovative and sustainable conservation activities on agricultural 

lands. 

—Strong partnerships with Anheuser-Busch, Southern Company, and the 

McKnight Foundation, all of whom have a special interest in conserving habitat 
176 

on private agricultural lands. New opportunities in 2009 for agriculture-focused 

partnerships include Syngenta and Perdue. 

IMPLEMENTATION OF STRATEGIC CONSERVATION INITIATIVES

It is widely known that climate change will endanger some wildlife populations 

and ecosystems more than others. In fiscal year 2008, the Foundation initiated 

grant-making through new keystone initiatives, which focus on select species of 

birds, fish and sensitive habitats. With support from the subcommittee in fiscal year 

2010, we will accelerate implementation of these strategic initiatives, many of which 

seek to address the affects of climate change through wildlife and natural resource 

adaptation. To ensure success in these investments, we are incorporating monitoring 

and evaluation into the entire lifecycle of our strategic initiatives in order to measure progress, promote adaptive management, demonstrate results, and continuously 

learn from our grant-making. With our partners, the Foundation has identified several species and ecosystems in need of immediate conservation action, a few of 

which are described below. 

Southeastern Grasslands.—Loss of native grasslands in the Southeast has dramatically reduced populations of grassland birds, such as the Northern Bobwhite 

and Loggerhead Shrike. Despite intensive efforts to improve habitat for these species, efforts have been disjointed and ineffective at recovering species. The Foundation will work with NRCS, other Federal agencies, and corporate partners to facilitate ongoing and new efforts toward effective and results-oriented grassland bird 

conservation. Fiscal year 2010 funding would support grassland restoration and 

management on private agricultural lands in the Southeast and, in turn, positively 

benefit wildlife conservation and associated recreation, erosion control and water 

quality. 

Northeastern Early Successional Forests.—The state fish and wildlife agencies in 

the Northeast have identified habitats that depend on disturbance as a top priority 

for their investments. Fiscal year 2010 funds will strengthen the Foundation’s partnership with NRCS to work with the States, farmers, family foresters and other 

landowners to create incentives to manage working lands that can support healthy 

wetland and forest wildlife. This includes controlling invasive species, using grazing 

as a win-win management tool, and other proactive efforts to keep declining species 

off the endangered species list. 

The Green River Basin of Wyoming.—Sublette County and other areas in the 

southwest corner of the State—are a major area for U.S. natural gas production and 

provide some of the highest quality sagebrush, riparian habitats and forest for wildlife in the west. The area also supports one of the strongest sage grouse populations, 

as well as mule deer, pronghorn and elk populations. Energy development impacts 

on wildlife movement and habitat are being addressed by energy companies, BLM 

and other government agencies. Our goal is to work with public and private partners to accelerate these efforts through several key strategies which include modifying fences and other barriers that obstruct wildlife movement, reducing road mortality along important migratory pathways, and protecting key parcels of private 

ranchland from development and subdivision with conservation easements. 

Sierra Nevada Alpine Wetlands.—We recognize that climate change will greatly 

exacerbate two existing water supply problems which impact wildlife and the public—too little water and the seasonality of freshwater supplies. The Foundation is 

working proactively with Federal, State and local partners to expand voluntary 

water transaction programs for private landowners and launching new initiatives to 

increase natural water storage. These efforts will benefit a diversity of wildlife species while improving water flows year-round for human use. For example, Sierra 

Nevada alpine wetlands, or ‘‘wet meadows’’, are hotspots within the Sierra Nevada 

ecosystem for wildlife diversity. Federal agencies manage about 40 percent of the 

area of these mountain ranges, but wet meadow habitat along valley bottoms is primarily private land. The Foundation will invest in partnerships that provide incentives to private landowners to conserve springs and wet meadows and provide artificial water sources to protect stream habitats. 

Klamath Basin.—The Foundation will be focusing on spring systems in the Klamath either by acquisition, easement, or voluntarily modifying agricultural practices 

as it is the soundest strategy for recovery of both endangered Suckers and Coho 

salmon. This strategy will provide these species and other fishes the ability to withstand climate change (resilience) much longer into this century. Similarly, an investment strategy of protecting and restoring spring systems in the Shenandoah River 

Basin will allow for the return of Eastern Brook Trout and 18–24 additional native 

species. In the Upper Colorado River Basin, locating areas at the warmwatercoldwater interface which contain Colorado Cutthroat trout and native suckers and 
177 

chubs is providing the framework to sustain these fishes into the next century, on 

both public and private lands. 

Restored funding through NRCS in fiscal year 2010 will also support the Foundation’s ongoing conservation grant programs including the Great Lakes Watershed 

Restoration Fund, Long Island Sound Futures Fund, and Chesapeake Bay Stewardship Fund. These grant programs, which effectively leverage funds from multiple 

Federal agencies and corporate partners, continued positive results in 2009 with priority project requests far exceeding available funds. 

EFFICIENCY, PERFORMANCE MEASURES AND ACCOUNTABILITY

As you know, the Foundation has taken important strides to strengthen our performance measures and accountability. For example, the Foundation is working 

with scientists and other experts to develop species-specific metrics for each of our 

keystone initiatives that we will use to measure our progress in achieving our conservation outcomes. Our grant review and contracting processes have been improved 

to ensure we maximize efficiency while maintaining strict financial and evaluationbased requirements. We have enhanced our website with interactive tools such as 

webinars and a grants library to enhance the transparency of our grant-making, 

and instituted a new paperless application and grant administration system. In 

2009, we will continue our efforts improve communication between and among our 

stakeholders and streamlining of our grant-making process. 

The Foundation’s grant-making involves a thorough internal and external review 

process. Peer reviews involve Federal and State agencies, affected industry, nonprofit organizations, and academics. Grants are also reviewed by the Foundation’s 

issue experts, as well as evaluation staff, before being recommended to the Board 

of Directors for approval. In addition, according to our Congressional Charter, the 

Foundation provides a 30-day notification to the Members of Congress for the congressional district and state in which a grant will be funded, prior to making a funding decision. 

Once again, Mr. Chairman, we greatly appreciate your continued support and 

hope the subcommittee will approve funding for the Foundation in fiscal year 2010. 

PREPARED STATEMENT OF THE NEW MEXICO INTERSTATE STREAM COMMISSION

Summary 

This statement is submitted in support of appropriations for the U.S. Department 

of Agriculture’s Environmental Quality Incentives Program (EQIP) and the Colorado 

River Basin Salinity Control Program. Prior to the enactment of the Farm Security 

and Rural Investment Act (FSRIA) in 2002, the salinity control program had not 

been funded at the level necessary to control salinity with respect to water quality 

standards since the enactment of the Federal Agriculture Improvement and Reform 

Act (FAIRA) of 1996. Inadequate funding of the salinity control program also negatively impacts the quality of water delivered to Mexico pursuant to Minute 242 of 

the International Boundary and Water Commission. Adequate funding for EQIP, 

from which the U.S. Department of Agriculture (USDA) funds the salinity program, 

is needed to implement salinity control measures. I request that the Subcommittee 

designate 2.5 percent, but no less than $20 million, of the EQIP appropriation for 

the Colorado River Basin salinity control program. I request that adequate funds 

be appropriated for technical assistance and education activities directed to salinity 

control program participants. 

Statement 

The seven Colorado River Basin States, in response to the salinity issues addressed by Clean Water Act of 1972, formed the Colorado River Basin Salinity Control Forum (Forum). Comprised of gubernatorial appointees from the seven Basin 

States, the Forum was created to provide for interstate cooperation in response to 

the Clean Water Act, and to provide the States with information to comply with Sections 303(a) and (b) of the act. The Forum has become the primary means for the 

seven Basin States to coordinate with Federal agencies and Congress to support the 

implementation of the Salinity control program. 

Congress authorized the Colorado River Basin salinity control program in the Colorado River Basin Salinity Control Act of 1974. Congress amended the act in 1984 

to give new responsibilities to the USDA. While retaining the Department of the Interior as the lead coordinator for the salinity control program, the amended act recognized the importance of the USDA operating under its authorities to meet the objectives of the salinity control program. Many of the most cost-effective projects undertaken by the salinity control program to date have occurred since implementa-
178 

tion of the USDA’s authorization for the program. Now, Congress is considering enactment of a new Farm Bill to further define how the Colorado River Basin States 

can cost-share in a newly designated salinity control program known as the ‘‘Basin 

States Program.’’ 

Bureau of Reclamation studies show that quantified damages from the Colorado River to United States water users are about $350,000,000 per year. Unquantified 

damages are significantly greater. Damages are estimated at $75,000,000 per year 

for every additional increase of 30 milligrams per liter in salinity of the Colorado 

River. It is essential to the cost-effectiveness of the salinity control program that 

USDA salinity control projects be funded for timely implementation to protect the 

quality of Colorado River Basin water delivered to the Lower Basin States and Mexico. 

Congress concluded, with the enactment FAIRA in 1996, that the salinity control 

program could be most effectively implemented as a component of EQIP. However, 

until 2004, the salinity control program since the enactment of FAIRA was not funded at an adequate level to protect the Basin State-adopted and Environmental Protection Agency approved water quality standards for salinity in the Colorado River. 

Appropriations for EQIP prior to 2004 were insufficient to adequately control salinity impacts from water delivered to the downstream States, and hampered the required quality of water delivered to Mexico pursuant to Minute No. 242 of the International Boundary and Water Commission, United States and Mexico. 

EQIP subsumed the salinity control program without giving adequate recognition 

to the responsibilities of the USDA to implement salinity control measures per Section 202(c) of the Colorado River Basin Salinity Control Act. The EQIP evaluation 

and project ranking criteria target small watershed improvements which do not recognize that water users hundreds of miles downstream are significant beneficiaries 

of the salinity control program. Proposals for EQIP funding are ranked in the States 

of Utah, Wyoming and Colorado under the direction of the respective State Conservationists without consideration of those downstream, particularly out-of-state, 

benefits. 

Following recommendations of the Basin States to address the funding problem, 

the USDA’s Natural Resources Conservation Service (NRCS) designated the Colorado River Basin an ‘‘area of special interest’’ including earmarked funds for the salinity control program. The NRCS concluded that the salinity control program is different from the small watershed approach of EQIP. The watershed for the salinity 

control program stretches almost 1200 miles from the headwaters of the river 

through the salt-laden soils of the Upper Basin to the river’s termination at the Gulf 

of California in Mexico. NRCS is to be commended for its efforts to comply with the 

USDA’s responsibilities under the Colorado River Basin Salinity Control Act, as 

amended. Irrigated agriculture in the Upper Basin realizes significant local benefits 

of improved irrigation practices, and agricultural producers have succeeded in submitting cost-effective proposals to NRCS. 

Years of inadequate Federal funding for EQIP since the 1996 enactment of FAIRA 

and prior to 2004 resulted in the Forum finding that the salinity control program 

needs acceleration to maintain the water quality criteria of the Colorado River 

Water Quality Standards for Salinity. Since the enactment of FSRIA in 2002, an 

opportunity to adequately fund the salinity control program now exists. The requested funding of 2.5 percent, but no less than $20 million, of the EQIP funding 

will continue to be needed each year for at least the next few fiscal years. 

State and local cost-sharing is triggered by and indexed to the Federal appropriation. Federal funding for the NRCS salinity control program of about $18 million 

for fiscal year 2009 has generated about $13.8 million in cost-sharing from the Colorado River Basin States and agricultural producers, or more than a 75 percent 

match of the Federal funds appropriated for the fiscal year. 

USDA salinity control projects have proven to be a most cost-effective component 

of the salinity control program. USDA has indicated that a more adequately funded 

EQIP program would result in more funds being allocated to the salinity program. 

The Basin States have cost-sharing dollars available to participate in on-farm salinity control efforts. The agricultural producers in the Upper Basin are willing to costshare their portion and are awaiting funding for their applications to be considered. 

The Basin States expend 40 percent of the State funds allocated for the program 

for essential NRCS technical assistance and education activities. Previously, the 

Federal part of the salinity control program funded through EQIP failed to adequately fund NRCS for these activities, which has been shown to be a severe impediment to accomplishing successful implementation of the salinity control program. Recent acknowledgement by the administration that technical assistance and 

education activities must be better funded has encouraged the Basin States and 

local producers that cost-share with the EQIP funding for implementation of the es-
179 

sential salinity control work. I request that adequate funds be appropriated to 

NRCS technical assistance and education activities directed to the salinity control 

program participants (producers). I urge the Congress to appropriate at least $1 billion in fiscal year 2010 for EQIP. Also, I request that Congress designate 2.5 percent, but no less than $20 million, 

of the EQIP appropriation for the Colorado River Basin salinity control program. 

PREPARED STATEMENT OF THE ORGANIC FARMING RESEARCH FOUNDATION

The Organic Farming Research Foundation’s funding requests for the fiscal year 

2010 Agriculture, Rural Development, Food and Drug Administration, and Related 

Agencies Appropriations Bill are to protect mandatory funding and to allocate $54.7 

million in discretionary funds, divided among agencies and programs in the following manner: 

—USDA—Cooperative State Research, Extension, and Education Service 

—Organic Agriculture Research and Extension Initiative 

Fiscal year 2009 actual: $18 million 

USDA fiscal year 2010 request: protect mandatory funding 

OFRF fiscal year 2010 request: protect mandatory funding plus $5 million 

discretionary 

—‘‘Organic Transitions’’ Integrated Research 

Fiscal year 2009 actual: $1.8 million 

USDA fiscal year 2010 request: $1.8 million 

OFRF fiscal year 2010 request: $5 million 

—USDA—Agricultural Research Service 

—Direct Organic Projects 

Fiscal year 2009 actual: $16.9 million 

USDA fiscal year 2010: N/A 

OFRF fiscal year 2010 request: $33 million 

—Includes ‘‘Organic Research Clearinghouse,’’ National Agricultural Library: 

$250,000 

—USDA—Agricultural Marketing Service/Economic Research Service/National 

Agricultural Statistics Service 

—Organic Production and Market Data Initiatives 

Fiscal year 2009 actual: $500,000 appropriated and $5 million one-time 

mandatory from 2008 Farm Bill 

USDA fiscal year 2010 request: $0 

OFRF fiscal year 2010 request: $5 million 

—USDA—Agricultural Marketing Service 

—National Organic Program 

Fiscal year 2009 actual: $3.8 million 

USDA fiscal year 2010 request: $6.7 million 

OFRF fiscal yea 2010 request: $6.7 million 

Details and further information on these programs is provided below. 

The Organic Farming Research Foundation (OFRF) appreciates the opportunity 

to present our funding requests for the fiscal year 2010 Agriculture, Rural Development, FDA, and Related Agencies Appropriations Bill. OFRF is a grower-directed, 

non-profit foundation working to foster the improvement and widespread adoption 

of organic farming systems. Organic agriculture plays an important and growing 

role in U.S. agriculture. Relatively modest investments in organic research and education can significantly increase the economic benefits and environmental services 

provided by organic farming systems and the organic products sector. As a result, 

we urge the Subcommittee to provide additional resources for organic agriculture in 

fiscal year 2010. 

The Organic Farming Research Foundation appropriations requests for fiscal year 

2010 reflect a coordinated set of activities that will strategically build upon the 

growth of organic agriculture and leverage the sector’s role in addressing the Nation’s economic, climate, and energy challenges. Organic agriculture continues to be 

a growing sector in U.S. agriculture, despite the economic recession. The organic 

products sector provides jobs on- and off-farm, provides increased marketing opportunities for farmers and processors, and meets widespread consumer demand for 

more food grown in an environmentally-sound manner. Emerging research is showing that organic agricultural systems provide a comprehensive strategy for mitigating the effects of climate change and facilitating the adaptation to climate 

change. Organic agriculture also reduces the use of non-renewable sources of energy 

such as fossil fuels. The multiple benefits of organic production systems make organic agriculture an effective vehicle for achieving national economic and environ-
180 

1The fair-share benchmark compares the U.S. retail market share of organic products to the 

percentage of USDA–REE spending on activities explicitly directed towards organic farming and 

food. 2OFRF estimates total fiscal year 2009 organic REE spending at $48 million, out of approximately $2.4 billion for the REE Mission Area. This includes: OREI ($18 million), ORG ($1.8 million), ARS direct-organic ($16.9 million), ODI ($5 million), other CSREES grants ($6 million). 3The Organic Agriculture Research and Extension Initiative (OREI) is authorized by Section 

1672B of the Food, Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5925b) as amended by Section 7206 of the Food, Conservation, and Energy Act of 2008. 4 ‘‘Organic Transitions’’ Integrated Research (ORG) is authorized by Section 406 of the Agricultural Research, Extension, and Education Reform Act of 1998 (AREERA) (7 U.S.C. 7626). 5 $1,8 million for fiscal year 2009. 

mental goals. This growth has been facilitated by the Subcommittee and was supported by the 2008 Farm Bill. 

OFRF’s recommendations emphasize research, data collection, and information 

dissemination. In our view, these are the most limiting factors for the growth and 

improvement of organic agriculture. Within the USDA—REE Mission Area, the support of the Subcommittee and the Department has been usefully tracked by the 

‘‘fair-share’’ comparison.1 Currently, organic product sales are approaching 4 percent 

of the domestic retail market, yet USDA–REE expenditures directed explicitly to research and information programs for organic agriculture have only just reached 2 

percent of the REE Mission Area funding.2 This discrepancy is detrimental to an 

industry that relies intensively on management and information for its success. By 

providing modest increases as outlined below, the Subcommittee can help meet the 

‘‘fair-share’’ benchmark for organic research and promote the multiple public benefits that organic farming can provide. 

USDA—COOPERATIVE STATE RESEARCH, EXTENSION, AND EDUCATION SERVICE

Organic Agriculture Research and Extension Initiative (OREI) 3

OFRF Fiscal Year 2010 Request: $25 million (protect mandatory funding plus 

$5 million discretionary) 

OREI is USDA’s premier competitive research and education grant program specifically dedicated to the investigation of organic agriculture. Due to its success with 

very modest funding, the program received an increase in mandatory funding in the 

2008 Farm Bill. Despite this increase, the program remains heavily oversubscribed. 

For the fiscal year 2009 allocation of $18 million, the program received applications 

totaling over $98 million. Increasing organic research capacities within the land 

grant university system and elsewhere are reflected in this trend. 

The 2008 Farm Bill allocates mandatory funding of $20 million to OREI for fiscal 

year 2010. The legislation also recognizes the need for further increases to reach the 

full potential of this program and authorizes discretionary funding of up to $25 million annually. In addition to protecting the full mandatory allocation, OFRF recommends appropriating $5 million of the discretionary authority in fiscal year 2010. 

This modest additional increase would continue making progress towards the fairshare benchmark of USDA research and education for organic agriculture and respond to the strong demand and increased capacity for the program’s outcomes. 

‘‘Organic Transitions’’ Integrated Research (ORG) 4

OFRF Fiscal Year 2010 Request: $5 million 

ORG is the older and smaller of two USDA competitive grant programs dedicated 

to organic research and education. From 2003 to 2008, it was administered together 

with OREI. Starting in fiscal year 2009, USDA–CSREES is instead combining the 

program with the 406 Integrated Water Quality research program. The newly combined program will fund multi-year projects that examine the effects of organic production systems on water quality. This approach provides a ‘‘specialized’’ complement to the general purposes of OREI, and OFRF supports this move by the 

agency. At current funding levels,5 this program can only fund a small number of 

serious investigations. Our request of $5 million for fiscal year 2010 seeks to enable 

a higher level of program performance and help reach the overall organic fair-share 

benchmark. 
181 

6 Communications from ARS national program staff, April 29, 2009. A larger total is reported 

to Congress, combining ‘‘direct organic’’ projects with ‘‘indirect organic’’ projects, as determined 

by ARS staff. 7Organic Research Action Plan: http://www.ars.usda.gov/SP2UserFiles/Program/216/ 

OrganicResearchActPlan.pdf. 8 ‘‘Report and Recommendations from a Focus Session on Organic Agriculture Conducted at 

the Advisory Board Meeting held in Washington, D.C. on October 29–31, 2007.’’ Page 4. National Agricultural Research, Extension, Education, and Economics Advisory Board. Transmitted 

to the Secretary of Agriculture and the House and Senate Committees on Appropriations, and 

Agriculture, March 5, 2008. 9The Organic Market and Production Data Initiatives is authorized by Section 7407 of the 

Farm Security and Rural Investment Act of 2002 as amended by Section 10302 of the Food, 

Conservation, and Energy Act of 2008. 11 For an update on the use of the funds, see ‘‘U.S. Department of Agriculture Report to Congress: Status of Organic Production and Market Data Activities As Required by the 2008 Farm 

Bill.’’ December 2008. 

USDA—AGRICULTURAL RESEARCH SERVICE

Direct Organic Projects 

OFRF Fiscal Year 2010 Request: $33 million (‘‘fair share’’ for ARS organic research) 

USDA—Agricultural Research Service has an organic research portfolio and a 

strategic plan for further organic research activities. The current funding for direct 

organic projects is $16.9 million, about 1.5 percent of the total ARS budget.6 We are 

urging growth of the agency’s direct organic activity to reach an ARS fair-share objective of $33 million. The increase should be pointed towards full implementation 

of the ARS Organic Research Action Plan.7

We ask that $250,000 be directed at funding the National Agricultural Library’s 

Alternative Farming Systems Information Center (NAL–AFSIC). As organic results 

proliferate, dissemination of information becomes a critical limiting factor for the 

overall goals of widespread adoption. The NAL–AFSIC program is well positioned 

to lead the dissemination function within USDA. OFRF estimates that maintenance 

and outreach for a national ‘‘clearinghouse’’ for organic agriculture, ‘‘enthusiastically’’ supported by USDA’s National Research Advisory Board,8 will require an ongoing annual budget allocation of $250,000. 

USDA—AGRICULTURAL MARKETING SERVICE/ECONOMIC RESEARCH SERVICE/NATIONAL

AGRICULTURAL STATISTICS SERVICE

Organic Production and Market Data Initiatives (ODI) 9

OFRF Fiscal Year 2010 Request: $5 million ($3 million for AMS, $1.5 million 

for ERS, and $0.5 million for NASS) 

Data on prices, yields, and markets are vital to farmers for production planning, 

market development, risk management, and obtaining financial credit. The organic 

sector is still without vital comprehensive data on par with what USDA provides 

for conventional agriculture, putting organic farmers at a significant disadvantage. 

The absence of marketing and production data specific to organic agriculture inhibits organic producers and handlers, and limits the effectiveness of policies enacted 

to facilitate the public benefits of organic agriculture. 

The Subcommittee has supported the initial 2002 authorization with $500,000 

from 2004 through 2009. These appropriations enabled a minimal baseline effort for 

general measurements of the organic sector. The 2008 Farm Bill provided $5 million 

in mandatory funds to jumpstart the combined data collection initiatives at AMS, 

ERS, and NASS. Those funds have already been spent on a variety of efforts at each 

of the agencies,11 including the development of a first-ever survey of organic agriculture by NASS to be released in early May 2009. 

Activities of AMS, ERS, and NASS require continued full support to build upon 

the previous investments. AMS has planned further enhancement of organic reporting and the development of additional organic market information tools. NASS is 

releasing its first-ever organic agriculture production survey in May, and will need 

funds to continue its data collection efforts. ERS will use additional targeted funds 

to continue expanding the agency’s overall program of research and analysis of organic agriculture, and will work jointly with NASS to analyze the data from the organic production survey. 

The 2008 Farm Bill provided additional authority up to $5 million annually for 

ODI. We are asking the Subcommittee to exercise its full authority and allocate $5 

million for fiscal year 2010 to organic data collection, distributed among the three 
182 

agencies leading this initiative. We anticipate that the President’s budget will recommend a similar allocation and agency distribution. 

USDA—Agricultural Marketing Service 

National Organic Program (NOP) 

OFRF Fiscal Year 2010 Request: $6.7 million 

NOP (including the National Organic Standards Board, organic standards setting, 

certifier accreditation and enforcement) received an increased authorization for appropriations in the 2008 Farm Bill. $8 million is the authorization level for fiscal 

year 2010. NOP has a large and growing number of important backlogged tasks. We 

support the President’s fiscal year 2010 request for $6.7 million. 

The Organic Farming Research Foundation thanks the Subcommittee for the opportunity to submit our requests. We ask the Subcommittee to provide funds to 

close the gap in research and education funding for organic agriculture, for the continued improvement and expansion of organic farming systems. 

Disclosure.—Organic Farming Research Foundation was a subcontractor for a 

grant awarded by the USDA–CSREES Integrated Organic Program. Grant# 2207– 

01384. ‘‘Midwest Organic Research Symposium.’’ 

PREPARED STATEMENT OF THE SOCIETY FOR WOMEN’S HEALTH RESEARCH

On the behalf of the Society for Women’s Health Research and the Women’s 

Health Research Coalition, we are pleased to submit testimony in support of increased funding for the Food and Drug Administration (FDA), and more specifically 

for the Office of Women’s Health (OWH), a critical focal point on women’s health 

within the Agency. 

The Society for Women’s Health Research is the Nation’s only non-profit organization whose mission is to improve the health of all women through advocacy, research, and education. Founded in 1990, the Society brought to national attention 

the need for the appropriate inclusion of women in major medical research studies 

and the need for more information about conditions affecting women exclusively, 

disproportionately, or differently than men. The Society advocates increased funding 

for research on women’s health; encourages the study of sex differences that may 

affect the prevention, diagnosis and treatment of disease; promotes the inclusion of 

women in medical research studies; and informs women, providers, policy makers 

and media about contemporary women’s health issues. 

In 1999, the Women’s Health Research Coalition was established by the Society 

to give a voice to scientists and researchers from across the country that are concerned and committed to improving women’s health research. The Coalition now has 

more than 650 members, including leaders within the scientific community and 

medical researchers from many of the country’s leading universities and medical 

centers, as well as leading voluntary health associations, and pharmaceutical and 

biotechnology companies. 

The Society and the Coalition are committed to advancing the health status of 

women through the discovery of new and useful scientific knowledge. We strongly 

believe that appropriate funding of the FDA by Congress is critical for the Agency 

to function and to assure the American public of the safety of its food and drugs. 

However, as has been well documented, currently the FDA is endeavoring to catch 

up after years of flat funding to meet the needs of scientific growth, innovation and 

development, and adequate food and drug protection. Further, FDA is struggling to 

catch up to present-day needs in the area of information technology (IT). 

Last year the FDA was awarded a $325 million increase to assist in revamping 

the Agency, as well as a one time investment of $150 million in supplemental funding. This influx of funds was meant to address years of chronic under-funding; however, the Agency needs a continuous stream of funding to address the myriad of infrastructure, resources and IT issues resulting from the budget shortages it has 

faced in the past decade. 

The Society urges Congress to provide the FDA with an increase of $386 million, 

bringing the FDA’s fiscal year 2010 budget to $2.425 billion. This funding increase 

will allow the FDA to continue rebuilding its infrastructure and addressing the 

shortage of resources was well as install IT systems that match the needs of the 

industries it is regulating and expectations of the American public. 

Another important investment that must be taken into account at the FDA is the 

Office of Women’s Health (OWH). OWH’s women’s health programs, often conducted 

with the Agency centers, are vital to maintaining focus on women’s health within 

the FDA. They are critical to improved care and increased awareness of disease-spe-
183 

cific impacts to women. For example, OWH ensures that sex and gender differences 

in the efficacy of drugs (such as metabolism rates), devices (sizes and functionality) 

and diagnostics are taken into consideration in reviews. To address OWH’s growing 

list of priorities, the Society recommends that Congress support a $7 million budget 

for OWH for fiscal year 2010 within the budget for the FDA. In addition, we further 

recommend that the current budget levels not only increase in the future, but 

should never be less than the $6 million that the office currently receives. 

FDA INFORMATION TECHNOLOGY SYSTEMS

The FDA is tasked with guarding the safety, efficacy, and security of human 

drugs, biological products, and medical devices. However, as was stated by the 

Science Board Report, requested by former Commissioner von Eschenbach, FDA’s IT 

systems were inefficient and incapable of handling the current demands placed on 

the Agency, thus preventing the FDA from fulfilling its mission. Equipment is outdated, often unsupported by maintenance, and regularly breaks down. FDA’s IT system, a system which needs to function 24/7, simply cannot keep up with current scientific data and market trends. This will only continue to worsen as servers’ age 

beyond usefulness, and serviceability and email networks fail multiple times per 

day. 

Additionally, the new Obama Administration is seeking to pass an overhaul of the 

Nation’s healthcare system. This reform is likely to include further advances to electronic health records and other IT innovations which will place an even greater burden on the FDA, among other agencies, to function within those advanced IT systems and networks. 

The antiquated nature of the IT systems also makes the agency unable to conduct 

safety analyses for product marketing applications, track the natural history and 

disease models for rare disorders, and access huge amounts of clinical data. The creation of a central database must happen to provide for a system query to a centralized repository for all relevant facts about a certain product including where, when 

and how the product was made. Such a uniform centralized database will be relevant for all information stored across agencies, so as to maximize functionality not 

only of FDA’s data but of expected research and analysis needed by the American 

public. 

Currently, the FDA receives large volumes of information in applications from 

drug manufacturers for review and evaluation. FDA reviewers must manually comb 

through the submitted drug trial reports and digital data in as many as twelve formats to evaluate a new drug’s safety and effectiveness. Frequently reviewers must 

handpick data manually from stacks of paper reports and craft their own data comparisons. This process is time consuming, makes the review process less efficient, 

and is error-prone and delays access to important information. Scientific and medical advances are occurring rapidly and the public needs and deserves access to the 

most recent and accurate information regarding their health. It is time Congress 

recognize that the Agency must utilize up-to-date information technology and that 

it sorely needs the resources to maintain them. 

The Society believes that the Agency and/or the FDA’s Office of Women’s Health 

should be able to track women or men and other subpopulations in all clinical trials 

before them and they are currently not able to do so. The FDA should be able to 

know how many women are in studies (both by recruitment and retention rates). 

This should be an immediate goal of any new IT system upgrade at the Agency in 

conjunction with the adoption of uniform data standards from which to pull the data 

and as part of the shift to an automated, electronic filing system. 

Estimations have shown that it would take $200 million ($40 million/year) over 

the course of 5 years to begin the process of improving the IT system. Congress 

must address past shortfalls to FDA and provide it a $386 million increase to begin 

IT transformation and many other improvements. 

OFFICE OF WOMEN’S HEALTH

OWH at the FDA, established in 1994, plays a critical role in women’s health, 

both within and outside the Agency, supporting sex- and gender-based research, 

areas in which the Society has long been a proponent. OWH provides scientific and 

policy expertise on sex and gender sensitive regulatory and oversight issues; endeavors to correct sex and gender disparities in the areas for which the FDA is responsible—drugs, devices, and biologics; and monitors women’s health priorities, providing both leadership and an integrated approach across the FDA. Despite inadequate funding, OWH provides all women with invaluable tools for their health. 

Each year OWH, with little difficulty, exhausts its tiny budget. OWH’s pamphlets 

are the most requested of any documents at the government printing facility in New 
184 

Mexico. Last year more than 5.6 million pamphlets are distributed to women across 

the Nation including target populations such as Hispanic communities, seniors and 

low-income citizens. Further, the Office attends over 125 meetings per year to exhibit, to present scientific posters and oral presentations, and to chair sessions. Despite its $1 million increase the office received last year, additional funding is needed so OWH may continue its present work on current projects, but expand and develop future projects. 

It is absolutely critical for Congress to take action now to help preserve the vital 

functions of OWH and to ensure that its small budget is dedicated to the resource 

needs of the office and to the projects and programs and research it funds. 

Since its beginning, OWH has funded high quality scientific research to serve as 

the foundation for Agency activities that improve women’s health. To date, OWH 

has funded over 100 research projects with approximately $19.9 million intramural 

grants, supporting projects within the FDA that address knowledge gaps or set new 

directions for sex and gender research. Extramural contracts leverage a wealth of 

expertise and other resources outside the FDA to provide insight on regulatory questions pertinent to women’s health. All contracts and grants are awarded through a 

competitive process. A large number of these studies are published and appear in 

peer reviewed journals. 

As part of its educational outreach efforts to consumers, OWH works closely with 

women’s advocacy and health professional organizations to provide clarity on the results of the Women’s Health Initiative. Due to OWH efforts, an informational fact 

sheet about menopause and hormones and a purse-sized questionnaire to review 

with the doctor were distributed to national and local print, radio, and Internet advertisements. OWH’s website, to date, has received over 3 million hits to download 

campaign materials. 

Further, OWH’s website serves as a vital tool for consumers and is constantly updated to include new and important health information. The website provides free, 

downloadable fact sheets on over 40 different illnesses, diseases, and health related 

issues. Recently OWH has completed medication charts on seven chronic diseases, 

which are unique within the Agency. These charts list all the medications that are 

prescribed and available for each disease. This information is ideal for women to use 

in talking to their doctors, pharmacists or nurses about their treatment options. 

OWH continues to improve the health of women through new research initiatives. 

Most recently, they have collaborated with Pharmacy Choice, Inc. to create a web 

portal solely dedicated to FDA consumer health education materials, providing access to fact sheets and medication guides. 

OWH and Sex Differences Research 

Scientists have long known of the anatomical differences between men and 

women, but only within the past decade have they begun to uncover significant biological and physiological differences. Sex differences have been found everywhere 

from the composition of bone matter and the experience of pain, to the metabolism 

of certain drugs and the rate of neurotransmitter synthesis in the brain. Sex-based 

biology, the study of biological and physiological differences between men and 

women, has revolutionized the way that the scientific community views the sexes, 

with even more information is forthcoming as a result of the sequencing of the X 

chromosome. The evidence is overwhelming, and as researchers continue to find 

more and complex biological differences, they gain a greater understanding of the 

biological and physiological composition of both sexes. 

Much of what is known about sex differences is the result of observational studies, 

or is descriptive evidence from studies that were not designed to obtain a careful 

comparison between females and males. The Society has long recognized that the 

inclusion of women in study populations by itself was insufficient to address the inequities in our knowledge of human biology and medicine, and that only by the careful study of sex differences at all levels, from genes to behavior, would science 

achieve the goal of optimal health care for both men and women. Many sex differences are already present at birth, whereas others develop later in life. These differences play an important role in disease susceptibility, prevalence, time of onset 

and severity and are evident in cancer, obesity, heart disease, immune dysfunction, 

mental health disorders, and other illnesses. Physiological and hormonal fluctuations may also play a role in the rate of drug metabolism and effectiveness of response in females and males. This research is supported and encouraged by the Office of Women’s Health within the Agency. OWH directly works with the various 

centers to advance the science in this area, collaborating on programs, projects, and 

research. 

Building upon sex differences research, the Society encourages the establishment 

of drug-labeling requirements that ensure labels include language about differences 
185 

experienced by women and men. Furthermore, we advocate for research on the comparative effectiveness of drugs with specific emphasis on data analysis by sex. When 

available, this information should be on labels. 

Our country’s drug development process has succeeded in delivering new and better medications to ensure the health of both women and men. However, the requirement that the data acquired during research of a new drug’s safety and effectiveness be analyzed as a function of sex or that information about the ways drugs may 

differ in various populations (e.g., women requiring a lower dosage because of different rates of absorption or chemical breakdown) be included in prescription drug 

labels and other patient educational and instructional materials is generally not enforced. 

The Society believes the opportunity to present this information to consumers is 

now. Sex differences data discovered from clinical trials can be directly related to 

the medical community and to consumers through drug labeling and packaging inserts and other forms of alerts. As part of advancing the need to analyze and report 

sex differences, the Society encourages the FDA to continue adequately addressing 

the need for accurate drug labeling in order to identify important sex and gender 

differences, as well as to ensure that appropriate data analysis of post-market surveillance reporting for these differences is placed in the hands of physicians and ultimately the patient. 

In conclusion, Mr. Chairman, we thank you and this Committee for its strong 

record of support for the FDA and women’s health and your commitment to OWH. 

We recommend that you increase the overall fiscal year 2010 budget for the FDA 

by $386 million, so that it may dramatically improve upon current operations while 

also rebuilding its IT infrastructure. Secondly, we urge you to allocate $7 million 

for the Office of Women’s Health for fiscal year 2010, and to ensure that future 

budget appropriations for the OWH are never below current funding levels. We look 

forward to continuing to work with you to build a stronger and healthier future for 

all Americans. 

PREPARED STATEMENT OF THE HUMANE SOCIETY OF THE UNITED STATES

As the largest animal protection organization in the country, we appreciate the 

opportunity to provide testimony to your subcommittee on fiscal year 2010 items of 

great importance to The Humane Society of the United States (HSUS) and its 11 

million supporters nationwide. In this testimony, we request the following amounts 

for the following USDA accounts: 

—FSIS/Humane Methods of Slaughter Act Enforcement—funding and language to 

improve enforcement (defer to subcommittee expertise for specific funding level) 

—FSIS/Horse Slaughter—language mirroring fiscal year 2009 omnibus provision 

—APHIS/Horse Protection Act Enforcement—at least $1 million 

—APHIS/Animal Welfare Act Enforcement—$22,275,270 

—APHIS/Investigative and Enforcement Services—$14,036,350 

—OIG/including Animal Fighting Enforcement—$87,910,150 

—CSREES/Veterinary Student Loan Forgiveness—$5,000,000 

—APHIS/Emergency Management Systems/Disaster Planning for Animals— 

$1,001,000 

—NAL/Animal Welfare Information Center—$1,978,400 

ENFORCEMENT OF ANIMAL WELFARE LAWS

We thank you for your outstanding support during recent years for improved enforcement by USDA of key animal welfare laws and we urge you to sustain this effort in fiscal year 2010. Your leadership is making a great difference in helping to 

protect the welfare of millions of animals across the country. As you know, better 

enforcement will also benefit people by helping to prevent: (1) food safety risks to 

consumers from sick animals who can transmit illness, and injuries to slaughterhouse workers from suffering animals; (2) orchestrated dogfights and cockfights that 

often involve illegal gambling, drug trafficking, and human violence, and can contribute to the spread of costly illnesses such as bird flu; (3) the sale of unhealthy 

pets by commercial breeders, commonly referred to as ‘‘puppy mills’’; (4) laboratory 

conditions that may impair the scientific integrity of animal-based research; (5) 

risks of disease transmission from, and dangerous encounters with, wild animals in 

or during public exhibition; and (6) injuries and deaths of pets on commercial airline 

flights due to mishandling and exposure to adverse environmental conditions. In 

order to continue the important work made possible by the Committee’s prior support, we request the following for fiscal year 2010: 
186 

FOOD SAFETY AND INSPECTION SERVICE/HUMANE METHODS OF SLAUGHTER ACT

ENFORCEMENT

We Request Funding and Language to Ensure Strengthened HMSA Enforcement.— 

We greatly appreciated the Committee’s inclusion of language calling on USDA to 

immediately close the downed cattle loophole, language that was indeed effective, 

as President Obama announced USDA’s new no-downed cattle rule just three days 

after he signed the omnibus into law. We also greatly appreciated the Committee’s 

inclusion of a $2 million increase in fiscal year 2009 to begin to address severe 

shortfalls in the agency’s oversight of humane handling rules for animals at slaughter facilities, oversight that is important not only for animal welfare but also for 

food safety. This problem came sharply into focus last year when egregious abuse 

of cattle was revealed from a 6-week hidden camera investigation of a plant—which 

happened to be the #2 beef supplier to the National School Lunch Program and had 

been honored by USDA as ‘‘Supplier of the Year’’ for the 2004–2005 academic year— 

leading to the nation’s largest meat recall in history. In that case, the blatant and 

recurrent violations of food safety and humane rules were not reported by 5 USDA 

inspection personnel at the plant. Subsequent undercover investigations showed the 

mistreatment was not an isolated case, and a USDA Inspector General’s audit identified several serious, continuing weaknesses in the inspection regime. We request 

funding and language to ensure that inspectors are continually observing live animals as they arrive and are offloaded and handled in pens, chutes, and stunning 

areas, and that USDA officials are taking strong action to avert violations of the 

Humane Methods of Slaughter Act and the ban on slaughter of cattle too sick or 

injured to stand and walk. We urge the Committee to make this a high priority in 

order to better protect consumers and animals. 

Specifically, we recommend a combination of measures to ensure meaningful compliance. More inspectors observing live animals are needed, and all inspectors 

should be trained and directed to monitor the treatment of live animals to ensure 

that they are handled humanely. Inspectors must understand that their oversight 

responsibilities begin at the moment animals arrive at slaughter premises, including 

when the animals are on trucks at slaughter facilities. An inspector should meet 

each truck when it arrives on the premises and should order the immediate humane 

euthanasia and condemnation of any cattle who are non-ambulatory. Egregious conduct such as forcefully striking an animal with an object, dragging an animal, ramming or otherwise attempting to move an animal with heavy machinery, or using 

electric shock, water pressure, or other extreme methods should be explicitly prohibited and those policies established in a formal rule to take effect immediately. Inspections should be unannounced and not on a predictable schedule. Oversight could 

be enhanced with video surveillance, accessible for viewing by independent third 

parties, but this should complement, not be a substitute for, improved inspections. 

Inspectors must be encouraged to report violations, rather than being discouraged 

from and even reprimanded for doing so by their superiors. Egregious humane handling violations must be noted through Noncompliance Reports and not just through 

Memoranda of Interview, so that documentation of these serious violations will be 

accessible through the PBIS system to other inspectors, USDA’s Office of Food Safety, Congress, and the public. Penalties should be more meaningful, particularly for 

repeat or egregious violations of humane handling standards. It would be helpful 

to rotate inspectors to ensure that they do not become too close with plant personnel, and undercover investigations by USDA personnel, under the OIG or otherwise, would bolster deterrence. 

HORSE SLAUGHTER

We Request Inclusion of Language Barring USDA From the Expenditure of Funds 

for Horse Slaughter Inspection.—Such language has been included in past years and 

has been vital to prevent renewed horse slaughter activity in this country. 

APHIS/HORSE PROTECTION ACT ENFORCEMENT

We Request at Least $1 Million for Strengthened Enforcement of the Horse Protection Act.—Congress enacted the Horse Protection Act (HPA) in 1970 to end the cruelty and abuse of ‘‘soring’’—a practice in which unscrupulous trainers use a variety 

of methods to inflict pain on sensitive areas of Tennessee Walking Horses’ feet and 

legs in an effort to exaggerate their high-stepping gait and gain an unfair competitive advantage at industry horse shows. For example, caustic chemicals—such as 

mustard oil, diesel fuel, kerosene, and industrial cleaners—are painted on the lower 

front legs of a horse. Then, the horse’s legs are wrapped in plastic wrap and tight 

bandages to ‘‘cook’’ the chemicals deep into the horse’s flesh. Sored horses are often 
187 

left standing in their stalls for days with their legs coated and wrapped. This makes 

the horse’s legs extremely painful and sensitive, and can result in permanent damage or even death in some cases. It is not uncommon to see sored horses lying down 

in their stalls, moaning in pain. When ridden, the horse is fitted with chains that 

slide up and down the horse’s sore legs, forcing him to produce an exaggerated, 

high-stepping gait in the show ring. In addition, other chemicals such as salicylic 

acid are used to slough off the scarred tissue and granulomas in an attempt to disguise the sored areas, a practice that is equally painful and cruel to these horses. 

When shown, some Tennessee Walking horses are fitted with heavy stacked shoes. 

Another particularly egregious form of soring—known as pressure shoeing—involves 

cutting a horse’s hoof almost to the quick, paring it down to the sensitive live tissue 

and causing an extreme amount of pain every time the horse bears weight on the 

hoof. To further increase the pain in the horse’s feet, foreign objects such as metal 

screws or acrylic are often inserted between the stacks and the horse’s hoof. 

Though soring has been illegal for almost 40 years, this cruel practice continues 

unabated by the well-intentioned but seriously understaffed APHIS inspection program. The most effective way to meet the goal of the Horse Protection Act is to have 

Animal Care inspectors present at the shows. Exhibitors who sore their horses go 

to great lengths to avoid detection, including fleeing a show when USDA inspectors 

arrive. Unfortunately, given an enforcement budget that has remained static at 

around $500,000 since 1976, Animal Care is able to attend only about 6 percent of 

the more than 500 Tennessee Walking Horse shows held annually. Funding of at 

least $1 million in fiscal year 2010 will begin to address the need for additional inspectors, training, security (to address threats of violence against inspectors), and 

advanced detection equipment (thermography and gas chromatography/mass spectrometry machines) to give agency officials the tools they need to meaningfully enforce this law as Congress intended. 

APHIS/ANIMAL WELFARE ACT ENFORCEMENT

We Request $22,275,270 (Near Level Funding) for AWA Enforcement Under the 

Animal and Plant Health Inspection Service (APHIS).—We commend the Committee 

for responding in recent years to the urgent need for increased funding for the Animal Care division to improve its inspections of almost 16,000 sites, including commercial breeding facilities, laboratories, zoos, circuses, and airlines, to ensure compliance with AWA standards. As part of the 2008 Farm Bill, Congress established 

a new responsibility for this division—to enforce a ban on imports from foreign 

puppy mills where puppies are mass produced under inhumane conditions and then 

forced to endure harsh long-distance transport, so that many arrive ill or dead or 

die soon after being sold to an American family. Animal Care currently has 111 inspectors (with 5 vacancies in the process of being filled), compared to 64 inspectors 

at the end of the 1990s. An appropriation at the requested level would maintain fiscal year 2009 funding with a modest increase to cover pay costs and additional responsibilities associated with the new import ban and the increasing number of licensed/registered facilities. 

APHIS/INVESTIGATIVE AND ENFORCEMENT SERVICES

We Request $14,036,350 (Near Level Funding) for APHIS Investigative and Enforcement Services (IES).—We appreciate the Committee’s consistent support for 

this division, which handles many important responsibilities, including the investigation of alleged violations of Federal animal welfare laws and the initiation of appropriate enforcement actions. The volume of animal welfare cases is rising significantly as new facilities become licensed and registered. An appropriation at the requested level would maintain fiscal year 2009 funding with a modest increase to 

cover pay costs. 

OFFICE OF INSPECTOR GENERAL/ANIMAL FIGHTING ENFORCEMENT

We Request $87,910,150 (Near Level Funding) for the Office of Inspector General 

(OIG) to Maintain Staff, Improve Effectiveness, and Allow Investigations in Various 

Areas, Including Enforcement of Animal Fighting Laws.—We appreciate the Committee’s inclusion of funding and language in recent years for USDA’s OIG to focus 

on animal fighting cases. Congress first prohibited most interstate and foreign commerce of animals for fighting in 1976, tightened loopholes in the law in 2002, established felony penalties in 2007, and further strengthened the law as part of the 2008 

Farm Bill, in the wake of the high-profile Michael Vick dogfighting case. We are 

pleased that USDA is taking seriously its responsibility to enforce this law, working 

with State and local agencies to complement their efforts and address these barbaric 

practices, in which animals are drugged to heighten their aggression and forced to 
188 

keep fighting even after they’ve suffered grievous injuries. Dogs bred and trained 

to fight endanger public safety, and some dogfighters steal pets to use as bait for 

training their dogs. Cockfighting was linked to an outbreak of Exotic Newcastle Disease in 2002–2003 that cost taxpayers more than $200 million to contain. It’s also 

been linked to the death of a number of people in Asia reportedly exposed through 

cockfighting activity to bird flu. Given the potential for further costly disease transmission, as well as the animal cruelty involved, we believe it is a sound investment 

for the Federal government to increase its efforts to combat illegal animal fighting 

activity. We also support the OIG’s auditing and investigative work to improve compliance with the humane slaughter law and downed animal rules and the Horse 

Protection Act. 

COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE/VETERINARY

STUDENT LOAN FORGIVENESS

We Request $5,000,000 to Continue the Implementation of the National Veterinary 

Medical Service Act (Public Law 108–161), Specifically Authorized in 2003.—This 

program received $2,950,000 in fiscal year 2009, and was projected to need 

$5,000,000 in its third year under the CBO score accompanying authorization. We 

appreciate that Congress is working to address the critical shortage of veterinarians 

practicing in rural and inner-city areas, as well as in government positions at FSIS 

and APHIS. A 2009 Government Accountability Office report enumerating the challenges facing veterinary medicine identified that an inadequate number of veterinarians to meet national needs is among the foremost challenges. A 2006 study 

demonstrated the acute and worsening shortage of veterinarians working in rural 

farm animal practice, while domestic pets in both rural and urban areas are often 

left without necessary medical care. Having adequate veterinary care is a core animal welfare concern. To ensure adequate oversight of humane handling and food 

safety rules, FSIS must be able to fill vacancies in inspector positions. Veterinarians 

also support our nation’s defense against bioterrorism (the Centers for Disease Control estimate that 75 percent of potential bioterrorism agents are zoonotic—transmitted from animals to humans). They are also on the front lines addressing public 

health problems such as those associated with pet overpopulation, parasites, rabies, 

chronic wasting disease, and bovine spongiform encephalopathy (‘‘mad cow’’ disease). 

Veterinary school graduates face a crushing debt burden of $120,000 on average, 

with an average starting salary of $61,000. For those who choose employment in underserved rural or inner-city areas or public health practice, the National Veterinary 

Medical Service Act authorizes the Secretary of Agriculture to forgive student debt. 

It also authorizes financial assistance for those who provide services during Federal 

emergency situations such as disease outbreaks. 

APHIS/EMERGENCY MANAGEMENT SYSTEMS /DISASTER PLANNING FOR ANIMALS

We Request $1,001,000 (Level Funding) for Animal Care Under APHIS’ Emergency 

Management Systems Line Item.—Hurricanes Katrina and Rita demonstrated that 

many people refuse to evacuate if they are forced to leave their pets behind. The 

Animal Care division has been asked to develop infrastructure to help prepare for 

and respond to animal issues in a disaster and incorporate lessons learned from previous disasters. These funds will be used for staff time and resources to support 

State and local governments’ and humane organizations’ efforts to plan for protection of people with animals. The additional resources will enable the agency to participate, in partnership with FEMA, in the National Response Plan without jeopardizing other Animal Care programs. 

ANIMAL WELFARE INFORMATION CENTER

We Request $1,978,400 for AWIC.—These funds will enable AWIC to improve its 

services as a clearinghouse, training center, and educational resource to help institutions using animals in research, testing and teaching comply with the requirements of the Animal Welfare Act, including consideration of alternatives to minimize or eliminate the use of animals in specific research protocols. 

Again, we appreciate the opportunity to share our views and priorities for the Agriculture, Rural Development, FDA, and Related Agencies Appropriation Act of fiscal year 2010. We are grateful for the Committee’s past support, and hope you will 

be able to accommodate these modest requests to address some very pressing problems affecting millions of animals in the United States. Thank you for your consideration. 
189 

1The Food, Conservation, and Energy Act of 2008 (Section 10303: National Organic Program). 

PREPARED STATEMENT OF WHITEWAVE FOODS

My name is Kelly Shea, and I thank you for the opportunity to testify on behalf 

of WhiteWave Foods regarding the growth of the organic industry and our support 

for the U.S. Department of Agriculture National Organic Program. Specifically, we 

support providing the Program with $8 million as authorized by Congress. 

Headquartered in Broomfield, Colorado, WhiteWave Foods, a growing subsidiary 

of Dean Foods, is the home of several pioneer organic brands, including Horizon Organic, The Organic Cow, and Silk Soymilk. As the organic industry evolves, we continue to lead with insight, integrity, and an unwavering commitment to organic 

principles. With this in mind, we are strongly supportive of efforts to ensure the 

continued growth of the organic sector by providing additional funding for the U.S. 

Department of Agriculture (USDA) National Organic Program. 

The National Organic Program (NOP) is rapidly outgrowing its present resource capacity. With retail sales at $24 billion and continuing to grow, certified operations 

in excess of 26,000, and 98 accredited certifying agents operating globally, the current NOP budget continually struggles to keep up with growing demands. 

Consumer confidence is the key to growth in the organic market. Ensuring continued consumer confidence requires consistent and adequate enforcement of the organic rule to ensure the integrity of the USDA organic seal. Therefore, adequate 

funding is required to enable the NOP to hire additional staff and continue to do 

a credible job of re-accreditation and investigating non-compliances. Additional resources are needed for both addressing gaps in the regulations and increasing compliance and enforcement activity. The long run objective is to maintain the integrity 

of the USDA organic seal for consumers who are willing to purchase organic products, produced according to a set of sustainable practices voluntarily subscribed to 

by producers and processors, based on legislation and regulations they initiated 

nearly two decades ago. The baseline for the NOP for the 2009 fiscal year is approximately $3 million. 

However, a portion of the budget is, and has been, a ‘‘pass-through’’ for funding of 

the Federal-State Marketing Improvement Program (FSMIP). FSMIP provides 

matching funds to State Departments of Agriculture and other appropriate State 

agencies to assist in exploring new market opportunities for U.S. food and agricultural products, and to encourage research and innovation aimed at improving the 

efficiency and performance of the U.S. marketing system. 

To facilitate the continued expansion of the organic industry, we support fully funding the operations of the NOP at the $8 million level authorized by Congress.1

We are strongly supportive of an increase in funding that could be allocated towards 

strengthening the accreditation process (training, education, audit, review, and compliance) for domestic and foreign certifying agents who are certifying to the NOP; 

international standards recognition and conformity assessment; standards development (new standards needed and continuing to improve existing standards as the 

industry develops); and enforcement through audits, investigative compliance and 

review (the NOP receives over 100 complaints per year). 

We appreciate your consideration of our requests; we believe that this increased 

funding will be critical to the continued growth of the organic sector. We thank you 

for the opportunity to testify today and look forward to working with you in the future. 

PREPARED STATEMENT OF THE WILDLIFE SOCIETY

The Wildlife Society appreciates the opportunity to submit testimony concerning 

the fiscal year 2010 budgets for the Animal Plant Health Inspection Service 

(APHIS), Cooperative State Research, Education and Extension Services (CSREES), 

and Natural Resources Conservation Service (NRCS). The Wildlife Society represents over 8,000 professional wildlife biologists and managers dedicated to sound 

wildlife stewardship through science and education. The Wildlife Society is committed to strengthening all Federal programs that benefit wildlife and their habitats 

on agricultural and other private land. 

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

Wildlife Services (WS), a unit of APHIS, is responsible for controlling wildlife 

damage to agriculture, aquaculture, forest, range, and other natural resources, wildlife-borne diseases, and wildlife at airports. Its activities are based on the principles 

of wildlife management and integrated damage management, and are carried out 
190 

cooperatively with state fish and wildlife agencies. The President’s budget would allocate $345 million to this program. The Wildlife Society recommends that Congress 

increase funding for this important program in fiscal year 2010, to at least the fiscal 

year 2009 level of $351 million. 

COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE

The Renewable Resources Extension Act (RREA) provides an expanded, comprehensive extension program for forest and rangeland renewable resources. The 

RREA funds, which are apportioned to State Extension Services, effectively leverage 

cooperative partnerships at an average of four to one, with a focus on private landowners. The need for RREA educational programs is greater than ever today because of continuing fragmentation of ownership, urbanization, the diversity of landowners needing assistance, and increasing societal concerns about land use and the 

impact on natural resources including soil, water, air, wildlife and other environmental factors. The Wildlife Society recommends that the Renewable Resources Extension Act be funded at $30 million, as authorized in the 2008 Farm Bill. 

The McIntire-Stennis Cooperative Forestry Program is essential to the future of 

resource management on non-industrial private forestlands, as forest products are 

produced while conserving natural resources, including fish and wildlife. As demand 

for forest products grow, privately held forests will increasingly be needed to supplement supplies, but trees suitable for harvest take decades to produce. In the absence 

of long-term and on-going research, such as provided through McIntire-Stennis, the 

nation could be unable to meet future forest-product needs. We appreciate the over 

$27 million in funding allocated in the fiscal year 2009 omnibus and recommended 

in the fiscal year 2010 proposal, and encourage a further increase in fiscal year 

2010. 

NATURAL RESOURCES CONSERVATION SERVICE

The Farm Bill conservation programs are more important than ever given huge 

backlogs of qualified applicants for these programs, increased pressure on farmland 

from the biofuels boom, sprawling development, and the ongoing declines in wildlife 

habitat and water quality. We are very concerned by the proposed decreases in the 

Farm Bill conservation programs in fiscal year 2010. The Wildlife Society recommends that the Farm Bill conservation programs be funded at the levels mandated in the 2008 Farm Bill. In particular, we encourage full funding of the Wildlife 

Habitat Incentive Program at $85 million. In addition, we note that 4 million acres 

of Conservation Reserve Program contracts are expiring. CRP should be funded at 

a level that allows for full enrollment of authorized CRP acres. 

FARM SERVICE AGENCY

The Voluntary Public Access and Habitat Incentive Program was authorized by 

the 2008 Farm Bill, to encourage farmers and ranchers to allow public access on 

their lands. We support funding at $16.67 million per year for the period 2010–2012, 

as recommended by the President. 

Thank you for considering the views of wildlife professionals. We look forward to 

working with you and your staff to ensure adequate funding for wildlife conservation. 

PREPARED STATEMENT OF THE HUMANE SOCIETY OF THE UNITED STATES

On behalf of the undersigned animal welfare and horse industry organizations, 

with combined supporters exceeding 12 million, we submit the following testimony 

seeking an increase in funding for the USDA/APHIS Horse Protection Program to 

at least $1 million for fiscal year 2010. This funding is urgently needed to begin to 

fulfill the intent of the Horse Protection Act—to eliminate the cruel practice of 

soring—by allowing the USDA to strengthen its enforcement capabilities for this 

law. 

In 1970, Congress passed the Horse Protection Act to end soring, the intentional 

infliction of pain to the hooves and legs of a horse to produce an exaggerated gait, 

practiced primarily in the Tennessee Walking Horse show industry. The Act authorizes the USDA to inspect Tennessee Walking Horses and Racking Horses—in transport to and at shows, exhibits, auctions and sales—for signs of soring, and to pursue 

penalties against violators. Unfortunately, since its inception, enforcement of the act 

has been plagued by underfunding. As a result, the USDA has never been able to 

adequately enforce the act, allowing this extreme and deliberate cruelty to persist 

on a widespread basis. 
191 

The most effective way to eliminate soring and meet the goals of the Horse Protection Act is to have USDA officials present at more shows. Current funding levels 

allow USDA officials to attend only about 6 percent of more than 500 Tennessee 

Walking Horse shows held annually. As a result, the agency opted to institute an 

industry-run system of certified Horse Industry Organizations (HIO) inspection programs, which are charged with inspecting horses for signs of soring at the majority 

of shows. These groups license examiners known as Designated Qualified Persons 

(DQPs) to conduct inspections. To perform this function, they often hire industry insiders who have an obvious stake in preserving the status quo. 

Statistics clearly show that when USDA inspectors are in attendance to oversee 

shows, the numbers of noted violations are many times higher than at shows where 

industry inspectors alone are conducting the inspections. And when USDA inspectors do arrive at shows, many exhibitors load up and leave to avoid being caught 

with sored horses. Agency officials have stated that inspectors are wary of going outside of their designated inspection area to examine horses on trailers as they leave 

the show grounds or in the barn areas, for fear of harassment and physical violence 

from exhibitors. Recently, armed security has been utilized to allow such inspections, at additional expense to this program. The fact that exhibitors feel they can 

intimidate government officials without penalty is a testament to the inherent 

shortcomings of the current system. By all measures, the overall DQP program has 

been a failure—the only remedy is to abolish it or greatly reduce dependence on this 

conflicted industry-run program of self-regulation and give USDA the resources it 

needs to adequately enforce the act. 

Lack of a consistent presence by USDA officials at Tennessee Walking Horse 

shows, sales, exhibits and auctions has fostered a cavalier attitude among industry 

insiders, who have not stopped their abuse, but have only become more clandestine 

in their soring methods. The continued use of soring to gain an advantage in the 

show ring has tainted the Tennessee Walking Horse industry as a whole, and creates an unfair advantage for those who are willing to break the law in pursuit of 

victory. 

Besides the indefensible suffering of the animals themselves, the continued acceptance of sored horses in the show ring prevents those with sound horses from 

competing fairly for prizes, breeding fees and other financial incentives, while those 

horse owners whose horses are sored may unwittingly suffer property damage and 

be duped into believing that their now abused, damaged horses are naturally superior. 

Currently, the means of inspection involves a physical palpation by the inspector. 

New technologies, such as thermography and ‘‘sniffer’’ devices (gas chromatography/ 

mass spectrometry machines), have been developed, which can help inspectors identify soring more effectively and objectively. However, USDA has been unable to purchase and put enough of this equipment in use in the field, allowing for industry 

insiders to continually evade detection. With increased funding, the USDA could 

purchase this equipment and train more inspectors to use it properly, greatly increasing its ability to enforce the Horse Protection Act (HPA). 

The egregious cruelty of soring is not only a concern for animal protection and 

horse industry organizations, but also for veterinarians. Last year, the American Association of Equine Practitioners (AAEP) issued a white paper condemning soring, 

calling it ‘‘one of the most significant welfare issues faced by the equine industry.’’ 

It called for the abolition of the DQP Program, saying ‘‘the acknowledged conflicts 

of interest which involve many of them cannot be reasonably resolved, and these 

individuals should be excluded from the regulatory process.’’ The AAEP further stated, ‘‘The failure of the HPA to eliminate the practice of soring can be traced to the 

woefully inadequate annual budget of $500,000 allocated to the USDA to enforce 

these rules and regulations.’’ 

It is unacceptable that nearly 40 years after passage of the Horse Protection Act, 

the USDA still lacks the resources needed to end this extreme form of abuse. It is 

time for Congress to give our public servants charged with enforcing this Act the 

support and resources they want and need to fulfill their duty to protect these 

horses as effectively and safely as possible. 

We appreciate the opportunity to share our views about this serious problem, and 

thank you for your consideration of our request. 

(i) 

LIST OF WITNESSES, COMMUNICATIONS, AND 

PREPARED STATEMENTS 

Page 

Acheson, Dr. David, Associate Commissioner for Foods, Food and Drug Administration, Department of Health and Human Services ............................... 1 

Ad Hoc Coalition, Prepared Statement of the ....................................................... 113 

American: 

Farm Bureau Federation, Prepared Statement of the .................................. 115 

Honey Producers Association, Inc., Prepared Statement of the ................... 117 

Indian Higher Education Consortium, Prepared Statement of the .............. 122 

Public Power Association, Prepared Statement of the .................................. 126 

Society for: 

Microbiology, Prepared Statements of the.......................................... 126, 130 

Nutrition (ASN), Prepared Statement of the .......................................... 133 

Society of: 

Agronomy, Prepared Statement of the .................................................... 136 

Plant Biologists, Prepared Statement of the ........................................... 135 

Animal Welfare Institute, Prepared Statements of the ................................... 139, 142 

Bennett, Senator Robert F., U.S. Senator From Utah, Statement of .................. 3 

Bond, Senator Christopher S., U.S. Senator From Missouri, Statement of ........ 51 

Brownback, Senator Sam, U.S. Senator From Kansas: 

Questions Submitted by ................................................................................... 37 

Statements of...................................................................................................... 2, 48 

Cochran, Norris, Deputy Assistant Secretary, Office of Budget, Department 

of Health and Human Services ........................................................................... 1 

Cochran, Senator Thad, U.S. Senator From Mississippi: 

Prepared Statement of ..................................................................................... 50 

Questions Submitted by ................................................................................... 109 

Collins, Senator Susan, U.S. Senator From Maine: 

Questions Submitted by ................................................................................... 111 

Statement of ...................................................................................................... 51 

Colorado River Basin Salinity Control Forum, Prepared Statement of the ....... 143 

Colorado River Board of California, Prepared Statement of the ......................... 146 

Crop Science Society of America, Prepared Statement of the .............................. 136 

Durbin, Senator Richard J., U.S. Senator From Illinois, Question Submitted 

by ........................................................................................................................... 37 

Environmental Service Research Institute, Prepared Statement of the ............. 147 

Feinstein, Senator Dianne, U.S. Senator From California, Questions Submitted by ............................................................................................................ 33, 103 

Florida State University, Prepared Statement of ................................................. 150 

Friends of Agricultural Research—Beltsville, Inc., Prepared Statement of ....... 151 

Glauber, Dr. Joseph, Chief Economist, U.S. Department of Agriculture ............ 47 

Goodwill Industries International, Prepared Statement of .................................. 155 

Harkin, Senator Tom, U.S. Senator From Iowa: 

Prepared Statement of ..................................................................................... 79 

Questions Submitted by ................................................................................... 101 

Statement of ...................................................................................................... 79 

Izaak Walton League of America, Prepared Statement of the ............................ 153 
Page

ii 

Johnson, Senator Tim, U.S. Senator From South Dakota: 

Prepared Statement of ..................................................................................... 51 

Statement of ...................................................................................................... 50 

Kohl, Senator Herb, U.S. Senator From Wisconsin: 

Opening Statements of ...................................................................................... 1, 47 

Questions Submitted by................................................................................... 26, 90 

McGarey, Patrick, Director, Office of Budget Formulation and Presentation, 

Food and Drug Administration, Department of Health and Human Services ......................................................................................................................... 1

Merrigan, Dr. Kathleen, Deputy Secretary, Office of the Secretary, Department of Agriculture .............................................................................................. 47 

Minor Crop Farmer Alliance, Prepared Statement of the .................................... 155 

National: 

Coalition for Food and Agricultural Research, Prepared Statements of 

the.............................................................................................................. 156, 158 

Commodity Supplemental Food Program Association, Prepared Statement 

of the .............................................................................................................. 159 

Cooperative Business Association, Prepared Statement of the .................... 164 

Cotton Council, Prepared Statement of the ................................................... 166 

Environmental Service Center, Prepared Statement of the ......................... 168 

Fish and Wildlife Foundation, Prepared Statement of the ........................... 175 

Organic Coalition, Prepared Statement of the ............................................... 170 

Potato Council, Prepared Statement of the .................................................... 173 

New Mexico Interstate Stream Commission, Prepared Statement of the .......... 177 

Organic Farming Research Foundation, Prepared Statement of the .................. 179 

Reed, Senator Jack, U.S. Senator From Rhode Island, Questions Submitted 

by ........................................................................................................................... 108 

Sharfstein, Dr. Joshua M., Acting Commissioner, Food and Drug Administration, Department of Health and Human Services ............................................. 1 

Prepared Statement of ..................................................................................... 9 

Statement of ...................................................................................................... 4 

Society for Women’s Health Research, Prepared Statement of the ..................... 182 

Soil Science Society of America, Prepared Statement of the ............................... 136 

Steele, Dr. Scott, Budget Officer, U.S. Department of Agriculture ..................... 47 

The Humane Society of the United States, Prepared Statements of.............. 185, 190 

The Wildlife Society, Prepared Statement of ........................................................ 189 

Vilsack, Thomas, Secretary, Office of the Secretary, Department of Agriculture ................................................................................................................... 47 

Statement of ...................................................................................................... 52 

Prepared Statement of ..................................................................................... 54 

WhiteWave Foods, Prepared Statement of ............................................................ 189 
(iii) 

SUBJECT INDEX 

DEPARTMENT OF AGRICULTURE 

OFFICE OF THE SECRETARY

Page 

Acre Program Implementation and Training ........................................................ 101 

Additional Committee Questions ............................................................................ 90 

Advanced Biofuels .................................................................................................... 101 

Affordable Rental Housing ...................................................................................... 110 

Agricultural Inspectors at Homeland Security ..................................................... 105 

Agroforestry Research ............................................................................................. 72 

All Natural Labels for Poultry ................................................................................ 107 

American Recovery and Reinvestment Act funds ................................................. 62 

Animal: 

Antibiotics ......................................................................................................... 98 

Identification ..................................................................................................... 95 

Improvement Laboratory ................................................................................. 100 

Asian Citrus Psyllid ................................................................................................ 103 

Broadband ................................................................................................................ 90 

California Drought Assistance ................................................................................ 104 

Cap-and-Trade Legislation ...................................................................................... 109 

Catfish Inspection Program .................................................................................... 108 

Childhood Obesity .................................................................................................... 71 

Civil Rights .............................................................................................................. 90 

Corn-soy Blend ......................................................................................................... 87 

Country of Origin Labeling ........................................................................... 70, 76, 106 

Dairy ......................................................................................................................... 92 

Farmers ............................................................................................................. 111 

Price Support Program ..................................................................................... 99 

Direct Farm Payments Limitation Cap................................................... 66, 68, 71, 74 

Downer Cattle .......................................................................................................... 106 

Empowerment Zones ............................................................................................... 111 

FSA Computers ........................................................................................................ 102 

Food Safety: 

Assessments ...................................................................................................... 97 

Infrastructure ................................................................................................... 98 

Frozen Food Safety .................................................................................................. 105 

Global Food Security ............................................................................................... 84 

Humanitarian Food Aid Dollars ............................................................................. 64 

Improving Financial Integrity ................................................................................ 54 

Local Foods—Business and Industry Loan and Grant Program ......................... 101 

Low Milk Prices ....................................................................................................... 84 

Maine Flood Assistance ........................................................................................... 112 

Market Access Program .......................................................................................... 108 

McGovern-Dole International Food for Education Program ................................ 92 

Micro-enterprise Program ....................................................................................... 95 

Milk Income Loss Contract Program ..................................................................... 107 

National: 

Animal Identification System .......................................................................... 69 

Bio and Agro-defense Facility .......................................................................... 63 

Drought Mitigation Center .............................................................................. 74 

Institute of Food and Agriculture (NIFA) ...................................................... 91 

Education Request .................................................................................... 92 

Philadelphia School Lunch Program ...................................................................... 82 

Poultry Imports From China .................................................................................. 66 
Page

iv 

RHS Recovery Act Implementation ........................................................................ 110 

Recovery Act ............................................................................................................. 54 

Broadband Program......................................................................................... 73, 75 

Business and Industry Loans .......................................................................... 81 

Watershed Projects in Rhode Island ............................................................... 77 

Renewable Energy ................................................................................................... 94 

Program Direction ............................................................................................ 88 

Research ................................................................................................................... 98 

Funding at Land Grant Universities .............................................................. 67 

Resource Conservation and Development Councils (RC&Ds)............................ 93, 112 

Revenue Caps vs. Income Caps .............................................................................. 108 

Rural Community Forums ...................................................................................... 85 

Supplemental Revenue Assistance Program ......................................................... 69 

The New Homestead Act ......................................................................................... 86 

2008 Farm Bill Provisions ...................................................................................... 68 

USDA and DOE Collaboration ............................................................................... 102 

WIC ........................................................................................................................... 93 

Funding ............................................................................................................. 88 

WRP 2008 Farm Bill Program ................................................................................ 80 

Watershed Flood Prevention Operations Program Status ................................... 96 

Wildlife Habitat Incentives Program ..................................................................... 77 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION

Access Act ................................................................................................................. 16 

Additional: 

Committee Questions ....................................................................................... 26 

Staff ................................................................................................................... 25 

Requested in the Budget/Pay Costs ......................................................... 28 

Adulterated Pomegranate Juice ............................................................................. 29 

Animal Biotech Products ......................................................................................... 7 

Antibiotic Resistance ............................................................................................... 29 

Antiviral Team ......................................................................................................... 8 

Blood Team ............................................................................................................... 8 

Budget Request ........................................................................................................ 5 

Consumer Protective Team ..................................................................................... 8 

Cosmetic Safety ........................................................................................................ 33 

Cost of: 

Drug Development ............................................................................................ 24 

Inspections ........................................................................................................ 31 

Critical Path ............................................................................................................ 21, 32 

Initiative/Modernize Drug Development ........................................................ 44 

Demonstration Grants for Improving Pediatric Device Availability ................... 31 

Details of the Fiscal Year 2010 Budget ................................................................. 10 

Diagnostic Team ...................................................................................................... 8 

Drug Importation ..................................................................................................... 20 

Expermental Drugs ................................................................................................. 17 

FDA: 

New Plan for Food Safety and States’ Role .................................................... 26 

Regulation of Tobacco ....................................................................................... 29 

2009-H1N1 Flu Virus Response ...................................................................... 13 

2010 Budget Request ....................................................................................... 9 

Fern Labs ................................................................................................................. 32 

Fiscal Year 2009 Supplemental Funding ............................................................... 43 

Food Safety, White House Working Group ............................................................ 40 

Foreign Offices ......................................................................................................... 43 

GAO .......................................................................................................................... 37 

Generic Drugs .......................................................................................................... 28 

H1N1 Flu Virus ....................................................................................................... 7 

Hiring and IT ........................................................................................................... 15 

Human Resources/Hiring Issues ............................................................................ 42 

Legislative Initiatives .............................................................................................. 7 

Med Guides .............................................................................................................. 24 

Methicillin-Resistance Staphylococcus Aereua—MRSA ....................................... 30 

National Antimicrobial: 

Monitoring System ........................................................................................... 29 
Page

v 

National Antimicrobial—Continued 

Resistance Monitoring System ........................................................................ 41 

NCTR ........................................................................................................................ 18

New Authorities Requested in the Budget ............................................................ 28 

Office of Cosmetics and Colors ............................................................................... 30 

Office of Generic Drugs ........................................................................................... 44 

Performance Results ................................................................................................ 39 

Personalized Medicine ............................................................................................. 41 

Policy Proposals: Drug Importation and Generic Biologics .................................. 38 

Public Health Outcomes .......................................................................................... 4 

Rapid Response ........................................................................................................ 26 

Teams ................................................................................................................ 27 

Recent Funding Increases ....................................................................................... 9 

Safe: 

Drug: 

Usage .......................................................................................................... 23 

Use .............................................................................................................. 6 

Foods .................................................................................................................. 5 

Safer Medical Products ........................................................................................... 6 

Shortage Team ......................................................................................................... 8 

Strategic Framework ............................................................................................... 15 

Supplemental Funds ................................................................................................ 15 

Tobacco ..................................................................................................................... 22

Regulation ......................................................................................................... 39 

Tuberculosis: Drug Resistant TB and Diagnostic Tests for Children ................. 37 

Use of Antibiotics in Animals ................................................................................. 40 

Vaccine Team ........................................................................................................... 8 

Warning Letters ....................................................................................................... 20 

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