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Transforming Food Safety

+$318,318,000 / 718 FTE


The following table displays the budget authority and user fees for Transforming Food
Safety in the FY 2011 President’s Budget for FDA programs.

FY 2011 Resource Table


Dollars in millions
FY 2011
FY 2009 FY 2010 President’s
1
Program Enacted Appropriation Budget Request +/- 2010

Foods $643.545 $784.115 $846.007 +$61.892


Center 209.648 236.618 259.410 +22.792
Field Activities 433.897 547.497 586.597 +39.100
Animal Drugs and Feeds $90.864 $107.264 $109.583 +$2.319
Center 50.014 56.892 58.287 +1.395
Field Activities 40.850 50.372 51.296 +0.924
National Center for Toxicological Research $8.683 $10.376 $10.821 +$0.445
Headquarters and Office of the Commissioner $41.854 $51.161 $57.883 +$6.722
Other Rent and Rent Related $31.500 $28.963 $33.407 +$4.444
GSA Rental Payments $59.941 $67.485 $71.469 +$3.984
Total, Budget Authority $876.388 $1,049.364 $1,129.169 +$79.805
2
Reinspection Fee $0.000 $0.000 $13.928 +13.928
2
Export Certification Fee $0.000 $0.000 $4.385 +4.385
2
Food Registration and Inspection User Fee $0.000 $0.000 $220.200 +220.200
Total, Program Level $876.388 $1,049.364 $1,367.682 $318.318
1
Includes funds for Cosmetics, Dietary Supplements and Nutrition/Food Labeling activities
2
Proposed user fee

1. Initiative Summary:

The Transforming Food Safety Initiative reflects President Obama’s vision of a new food
safety system to protect the American public. FDA will set standards for safety, expand
laboratory capacity, pilot track and trace technology, strengthen its import safety
program, improve data collection and risk analysis, and begin to establish an integrated
national food safety system with stronger inspection and response capacity.

2. Why is this funding necessary?

Tens of millions of Americans suffer from foodborne illness each year, hundreds of
thousands are hospitalized, and thousands die. Recent outbreaks have left thousands of
consumers ill, and associated recalls have devastated industries. These events have
produced a consensus among consumers, industry and experts that our food safety system
needs fundamental change to prevent illness and restore public confidence.
In March 2009, President Obama established a Food Safety Working Group, and the
President directed the Working Group to design a food safety system focused on
prevention. On July 7, 2009, Vice President Biden announced the Working Group
recommendations for a new, public health-focused approach to food safety.

Vice President Biden emphasized the scope of the food safety challenge that we face:
“Our food safety system must be updated – 1 in 4 people get sick every year due to food-
borne illness, and children and the elderly are more at risk . . . Our inspectors and
scientists lack sufficient resources . . . Our goal is to overhaul the system so that we can
get better at both stopping food safety problems before they happen and almost equally as
important moving quickly – much more quickly – to deal with them when they do . . . we
want to make our new priority preventing those things from happening in the first place.”

Vice President Biden closed by adding, “The President has made food safety simply an
important national priority.”

Secretary Sebelius echoed these sentiments: “In just the past few months since we began
work with the Food Safety Working Group, we have seen recalls on everything from
spinach to peanut products to now even cookie dough. The Administration recognizes
that the current system just isn’t working for America’s families and under the
President’s leadership we are taking action to keep our food supply safe and prevent
outbreaks that can impact millions of Americans."

The resources in FDA’s FY 2011 Transforming Food Safety initiative will achieve the
Administration’s goal of establishing food safety as a national priority. FDA’s initiative
implements the three core principles announced on July 7 by the Food Safety Working
Group: prioritizing prevention, strengthening surveillance and enforcement, and
improving response and recovery. The FY 2011 resources for Transforming Food Safety
will begin to establish an integrated national food safety system that protects American
consumers against the dangers of food-borne illness.

In the text that follows, FDA identifies the components that contribute to this initiative.
Details about each component appear in the tab in the FY 2011 budget labeled
“Component Papers.”

3. What activities will the funds support?

FDA will use the funds in this initiative to support the three priorities established by the
President’s Food Safety Working Group.

A. Prioritizing Prevention: BA +$7,117,000 / 20 FTE; UF +$75,633,800 / 144 FTE

 FDA will set new standards for food safety. FDA will develop guidances and
binding regulations to serve as a foundation for a prevention-oriented food safety
system. New standards will include preventive controls, recordkeeping,
requirements for identifying food facilities, and program standards for inspections
and for collecting and analyzing samples. FDA will also develop standards for
enforcement, response, and recovery for use by FDA and its regulatory partners in
an integrated national system for food safety.
Component T-1: BA +$4,500,000 / 15 FTE; UF +$21,492,000 / 32 FTE

 FDA will begin to establish an integrated national food safety system focused
on prevention. FDA will conduct audits of regulatory and public health partners.
FDA audits will include reviews of inspection, investigation, sample collection
and analysis, enforcement, response, recovery and outreach activities. The audits
will measure performance against FDA food safety program standards. Through
the integrated system, FDA will substantially increase food inspections and
enhance feed surveillance.
Component T-3: BA +$396,000 / 1 FTE; UF +$19,746,800 / 50 FTE

 FDA will begin to establish a modern import safety program. FDA will
develop standards for evaluating food safety systems in foreign countries,
continue third-party certification efforts, and develop a registry of all importers.
FDA will also expand and strengthen efforts to leverage information and build
capacity with our trading partners. When fully implemented, this program will
hold imported and domestic foods to a common high standard of safety.
Component T-4: BA +$2,221,000 / 4 FTE; UF +$34,395,000 / 62 FTE

B. Strengthening Surveillance and Enforcement: BA +$53,693,000 / 111 FTE;


UF +$119,470,200 / 313 FTE

i. Strengthening Surveillance: BA +$36,778,000 / 105 FTE;


UF +$45,215,000 / 91 FTE

 FDA will enhance surveillance capabilities via the integrated national food
safety system. FDA will add state liaisons to provide program guidance and
direction. State liaisons will facilitate timely communication with our regulatory
and public health partners. FDA will also develop and implement a national work
plan for inspecting food manufacturing and distribution facilities and for
collecting and analyzing compliance, surveillance, and environmental samples.
Component T-3: BA +0; UF +$4,147,000 / 15 FTE

 FDA will enhance surveillance capacity as part of a modern import safety


program. FDA will gather data and evaluate food safety systems in foreign
countries. FDA will also collect 3,000 additional import samples. (BA = 0 /
UF = 3,000) Based on training requirements, the full performance year for the
increase in import sampling is FY 2012.
Component T-4: BA +$1,005,000 / 3 FTE; UF +$4,607,000 / 17 FTE

 FDA will improve risk analysis and research for food and feed safety. FDA
will expand its capacity to identify products at highest risk for contamination.
This will allow FDA to better target and prioritize food safety efforts and
sampling and inspection priorities. In addition, FDA will improve data collection
for risk analysis and detecting food safety signals. FDA will enhance the
reportable food registry to help consumers report problems with foods. FDA will
also expand the National Antimicrobial Resistance Monitoring System (NARMS)
surveillance and monitoring to test additional high-priority commodities such as
seafood and animal feeds. In partnership with CDC and USDA, FDA will adapt
the NARMS platform to monitor emerging pathogens in food animals and retail
foods of animal origin in the United States.
Component T-5: BA +$7,650,000 / 11 FTE; UF +$9,705,000 / 15 FTE

 FDA will expand laboratory capacity and capability. FDA will expand lab-
oratory capacity and establish a new mobile laboratory for remote, on-site testing.
FDA will increase its capacity to analyze and assess patterns in test results and
develop and deploy rapid tests to identify food and environmental contamination.
Component T-6: BA +$28,123,000 / 91 FTE; UF+$26,756,000 / 44 FTE

ii. Strengthening Enforcement: BA +$16,915,000 / 6 FTE;


UF +$74,225,200 / 222 FTE

 FDA will increase inspection capacity through the integrated national food
safety system. FDA will hire 94 new food safety inspectors (BA = 3 FTE; UF =
91 FTE). When fully trained, new inspectors will conduct an additional 1,978
domestic food inspections (BA = 0 / UF = 1,978), 228 domestic tissue residue
inspections (BA = 33 / UF = 195), and 159 additional foreign food inspections
(BA = 0 / UF = 159) each year. Based on training requirements, the full
performance year for the increase in domestic inspections is FY 2013. The full
performance year for the increase in foreign inspections is FY 2014.

With this funding, FDA also will increase the safety of food and animal feeds by
funding increased state sampling of feeds and feed ingredients. Finally, FDA will
begin to improve the efficiency of inspections and inspection analysis by
establishing a system to electronically exchange data between the states and FDA.
Component T-3: BA +$15,910,000 / 3 FTE; UF +$74,255,200 / 222 FTE

 FDA will increase inspection capacity through a modern import safety


program. As part of an import safety program, FDA will conduct audits of
foreign regulatory bodies and begin developing an updated inventory of foreign
facilities to support the increase in foreign inspections.
Component T-4: BA +$1,005,000 / 3 FTE; UF +0

C. Improving Response and Recovery: BA +$812,000 / 1 FTE;


UF +$938,000 / 2 FTE

 FDA will pursue pilot studies with industry using track and trace technology.
The track and trace studies will guide FDA as it develops food product tracing
regulation that provides for rapid tracing without overly burdening industry.
Component T-2: BA +$812,000 / 1 FTE; UF +$406,000 / 0 FTE

 FDA will expand laboratory capacity and capability to enhance response and
recovery. This investment focuses on developing technology to improve
response, recovery, and overall efficiency in food testing laboratories. By
developing this technology, FDA will be able to identify and confirm chemical
contaminants in food samples without any prior knowledge of the type of
compound present. The technology will also allow FDA to more rapidly subtype
and serotype priority pathogens. When fully deployed, this technology holds the
promise of reducing the time to conduct these pathogen screening analyses to one
to two days, compared to the current five to ten days.
Component T-6: BA + 0; UF +$532,000 / 2 FTE

D. Information Technology and Program Support for Initiative Priorities:


BA +$4,950,000 / 8 FTE; UF +$18,460,000 / 20 FTE

FDA will invest $10,000,000 in two information technology (IT) projects: enterprise
information technology and IT systems to establish, support, and maintain the systems
necessary to collect Food Registration and Inspection User Fees.

FDA has embarked on a multi-year effort to modernize its enterprise-wide IT


infrastructure. The FDA effort includes investments in IT systems to Transform Food
Safety. The FY 2011 IT investment will ensure that FDA can maintain an interoperable
system to share regulatory data across FDA food programs. The investment also supports
data centers, IT security, telecommunication networks, and related operations to support
FDA food programs.

The IT investment will support FDA’s ability to transform nearly every aspect of food
safety operations and regulatory activity. The resources in this initiative will also allow
FDA to enhance IT systems necessary to establish and collect the new Food Registration
and Inspection fees.
Component T-7: BA +0; UF +$10,000,000 / 5 FTE

In addition to enterprise IT investments, the Transforming Food Safety Initiative includes


resources to ensure that the food program offices that participate in this initiative receive
the support necessary to achieve the proposed public health outcomes. Support activities
include finance and budgeting, human resource assistance, legal counsel,
communications, ethics, headquarters coordination and other related support functions.
Component T-8: BA +$3,935,000 / 8 FTE; UF +$8,460,000 / 15 FTE

FDA will also configure existing office space to accommodate additional food safety
employees.
Component T-9: BA +$1,015,000, 0 FTE; UF +0
E. Food Registration and Inspection User Fees: +$220,200,000 / 479 FTE

The President’s FY 2011 budget includes $220,200,000 for user fees to register food
facilities and conduct import review and product sampling. The new fees will also allow
FDA to conduct additional food safety and good manufacturing practices inspections of
domestic and foreign facilities that manufacture and process the foods that Americans
consume. The new user fees will pay costs associated with activities that are necessary
for the safety and security of America’s food supply.

With these resources, FDA will increase its capacity to establish an integrated national
food safety system and further strengthen food safety inspection, response and import
review. Details of the allocation of the Food Registration and Inspection User Fees
appear throughout section 3 of this business case paper.

F. Reinspection User Fee: +$13,928,000 / 73 FTE

FDA is proposing a new user fee to require establishments that FDA inspects to pay the
full costs of reinspections and associated follow-up work. FDA will impose the user fee
when FDA reinspects facilities due to a failure to meet Good Manufacturing Practices
(GMPs) or other important FDA requirements.

When FDA identifies violations during an inspection or issues a warning letter following
an inspection, FDA conducts follow-up inspections to verify that the problem was
corrected. FDA procedures usually require that FDA conduct a follow-up inspection of
the firm within 90 days of issuing a warning letter.

Of the total FTE increase for this activity, FDA will hire 31 new food and feed safety
inspectors (BA = 0 FTE; UF = 31 FTE). When the new inspectors are fully trained, FDA
will have the capacity to conduct an additional 1,051 domestic food and feed
reinspections. (BA = 0 / UF = 1,051)

The Reinspection User Fee ensures that facilities that fail to comply with health and
safety standards bear the cost of the reinspection. If facilities that fail to comply with
FDA regulations do not bear the cost of reinspections, FDA must shift resources from
other high-priority public health activities to conduct facility reinspections. The proposed
Reinspection User Fee will also extend to FDA medical product programs.

G. Export Certification User Fee: +$4,385,000 / 26 FTE

FDA issues approximately 37,000 food and animal feed export certificates annually.
FDA currently funds this activity using discretionary appropriations.

The Administration is proposing legislation to authorize FDA to collect user fees for
issuing food and animal feed export certificates. FDA usually issues certificates within
20 days of receiving a request.
Exporters benefit from the enhanced ability to export their products. Under the
Administration’s proposal, exporters will also bear the cost of the Export Certificate
Program.

H. Pay Costs for FDA Food Safety Programs: +$4,805,000 / 0 FTE

FDA regulates a diverse and complex portfolio of products that accounts for 20 percent
of U.S. consumer spending. FDA can only fulfill its responsibilities if it has sufficient
resources to pay the scientific, professional and technical workforce required to conduct
FDA food safety programs. To maintain its workforce, FDA must continue to meet the
cost of payroll for its employees.

For food safety programs, the FY 2011 budget authority funding for higher pay costs is
$4.8 million. For all FDA programs, the budget authority for higher pay costs is $10.9
million during FY 2011.

I. Rent Activities for FDA Food Safety Programs +$8,428,000 / 0 FTE

The $8,428,000 increase in budget authority will allow FDA to pay rising GSA rent and
Other Rent and Rent-Related costs without requiring FDA to redirect resources away
from core, mission-critical public health activities. The increase in rental payments is
essential for FDA food safety programs to maintain performance and achieve their public
health goals.

The GSA Rent account includes funds for FDA payments to the General Services
Administration (GSA) for FDA’s office and laboratory facilities. GSA rent also includes
funds for payments to the Department of Homeland Security for guard services and the
operation of security systems at FDA facilities. The Other Rent and Rent-Related
account includes funds for commercial rent and other payments related to leased facilities
that are not part of the GSA inventory of buildings.

These funds pay costs of operating and maintaining the nation wide inventory of FDA-
owned, FDA-leased, and GSA-owned or leased space. Costs include commercial rent,
utilities, operation and maintenance contracts, janitorial and grounds maintenance
contracts, and security and guard services contracts.

GSA rent and Other Rent and Rent-Related costs support FDA public health operations.
These investments are essential for FDA food programs to achieve their public health
goals.

4. How does this initiative support important public heath priorities?

This initiative addresses a key Presidential priority for food safety and reflects the
framework and priorities developed by the President’s Food Safety Working Group. The
Transforming Food Safety initiative will allow FDA to begin to achieve an integrated
national food safety system that protects American consumers against the dangers of
food-borne illness.

5. What are the risks of not proceeding with the initiative?

A. Transforming Food Safety

The resources in this initiative will promote public health in the United States by
increasing the safety of America’s food supply. With these resources, FDA’s science-
based strategy will continue to build new and greater capability for food safety in the
years ahead.

Not funding this initiative will result in a food safety system that continues to imperil
public health, frustrate consumers, allow recurring outbreaks, devastate industries and
pose health risks from domestic and imported food.

Funding the Transforming Food Safety initiative will allow FDA to:

 Reduce the number of foodborne illnesses


 Identify sources of risk in the food safety system
 Improve industry compliance with food safety standards
 Reduce time to detect and respond to outbreaks
 Establish stronger links between performance outcomes and resource investments
 Enhance integration between Federal, State, local, and foreign public health
partners.

This initiative will benefit 300 million Americans, plus countless international consumers
who benefit from U.S. leadership in food safety and security. This initiative also offers
special benefits for the following populations and interests:

 Populations susceptible to foodborne illness, such as the young and elderly


 Populations suffering from chronic diseases, such as obesity, diabetes,
cardiovascular disease, and immune deficiencies
 Vulnerable populations suffering disparities in health
 The $1 trillion food production, processing, manufacturing, restaurant and retail
food industries
 Foreign trading partners who share economic and public health concerns and want
to continue to trade in raw, processed and finished human food and animal feed
with the United States.

B. Pay and Rent Activity Costs for FDA Food Safety Programs

For food safety programs, the FY 2011 budget authority increase for higher pay costs is
$4,805 million. For all FDA programs, pay costs will increase by $10.9 million.
The FY 2011 budget authority increase for Rent Activities to support food programs is
$8,428,000. For all FDA programs, the cost of Rent Activities will increase by $22.1
million.

Payroll, rent, utilities and other costs to support the FDA workforce account for 78
percent of the FDA budget. These are fixed costs that FDA does not control. If FDA
does not receive the full amount for increased pay and rent costs, FDA must absorb the
higher pay and rent costs by reducing essential staff. As a result, FDA will fail to hire or
replace inspectors, epidemiologists, safety experts and other professionals that are the
backbone of FDA’s food safety workforce.

On an FDA-wide basis, absorbing $33.0 million in higher pay and rent activity costs
during FY 2011 will result in the loss of 147 FTE. As a comparison, 147 FTE is
equivalent to more than half of the budget authority-funded staff that conducts and
supports animal drug and feed inspection activity or two-thirds of the budget authority-
funded staff that conducts and supports vaccine, blood, and other biologic inspection
activity.

If FDA does not receive the full amount necessary to pay the higher pay costs for its
employees and higher rent cost for its facilities, FDA must reduce the professional staff
that performs the FDA mission. Examples of the consequences of not approving the
higher pay and rent costs for food programs include a loss of field inspectors that support
and perform domestic and foreign food and feed safety inspections and a reduced
capacity to identify safety concerns through good manufacturing practice and Hazard
Analysis Critical Control Point (HACCP) inspections. Therefore, failing to fund this
initiative will limit FDA’s ability to protect the food that Americans consume every day.

6. What will FDA accomplish with the initiative?

This initiative will allow the Administration to deliver on its promise of improved food
safety for the American people. These accomplishments will provide a foundation for
substantially reducing illnesses caused by contamination of the food supply for years to
come.

Specific deliverables appear in the performance table below. In summary, this


investment will lead to:

 Many new, effective, and long overdue food safety standards


 Substantial new food inspection capacity
 A new integrated national food safety system with states and localities
 Improved data collection and risk analysis
 A new program for import safety
 Substantial new laboratory capacity to increase analysis of foods.
FY 2011 Transforming Food Safety Performance Table:
The following table contains information about performance commitments associated
with FDA’s proposed increase for Transforming Food Safety, including accomplishments
achieved during Fiscal Year 2009 and expected in Fiscal Year 2010, and proposed
program outputs to be achieved in Fiscal Year 2011.

For more information regarding the alignment of FDA's Strategic Action Plan goals and
objectives with each Center's or Office’s Subprogram areas and associated annual
performance goals, see the information on strategic alignment in the Performance
Materials Tab of this budget document.

Prioritizing Prevention

Program Outputs FY 2009 FY 2010 FY 2011 FY 2011


Actual Appropriation Request +/- FY 2010 PB
Number of National Publish 10 Publish 9
Update 10 existing + 9 final revised
Standards Developed draft revised final revised
standards standards
standards standards
Web-based training courses
0 0 1 +1
on national standard
Administrative and/or in-
country food safety system 0 0 5 +5
assessment
Percent of food facilities
(both domestic and foreign) Developmental
New
with effective preventive (seafood HACCP New Baseline TBD
Baseline
controls as required by FY08 actual = 91%)
federal law 1
Percent of retail and food
Developmental
service establishments with
(baseline by July, TBD TBD TBD
adequate controls for key
2009)
foodborne illness risk factors

Strengthening Surveillance and Enforcement


Program Outputs FY 2009 FY 2010 FY 2011 FY 2011
Actual Appropriation Request +/- FY 2010 PB
Review adverse experience
reports received to detect 44% 50% 56% +6%
animal product hazards early
FDA Domestic Food +968; will hire 158 FTE
Inspections and begin training in
7,165 7,470 8,438 FY11 (+1,978 by end of
2013; FY 11 BA = 0;
FY 11 UF = 1,978)

1
In FY 09, the percent is the cumulative compliance with FDA’s Seafood and Juice HACCP programs,
which are the preventive controls required by federal law in FY 09. In FY 10 and 11, if new food safety
legislation is enacted into law, FDA will establish a new baseline of programs for preventive controls.
Program Outputs FY 2009 FY 2010 FY 2011 FY 2011
Actual Appropriation Request +/- FY 2010 PB
FDA Foreign Food +394; will hire 19 FTE
Inspections and begin training in
FY11 (+159 inspections
210 600 994
by end of 2014; FY 11
BA = 0; FY 11 UF =
159)
FDA Domestic Illegal -143; will hire 21 FTE
Residue Program & begin training in
196 580 2 437 FY11 (+228 by end of
2013; FY 11 BA = 33;
FY 11 UF = 195)
Average number of days to 5-8 days
Baseline: 10-14
subtype priority pathogens in N/A (screening - 5 to 6 days
working days
food (screening only) only)
Average number of working
1-2 days
days to serotype priority Baseline: 8-15
N/A (screening - 6 to 13 days
pathogens in food (screening working days
only)
only)

Improving Response and Recovery


Program Outputs FY 2009 FY 2010 FY 2011 FY 2011
Actual Appropriation Request +/- FY 2010 PB
Use of Geospatial Information
10% increase 15% increase 25% increase
Systems during emergency response + 25%
over FY 2008 over FY 2009 over FY 2010
activities

2
The FY 2010 inspection estimate reflects an added assignment. The lower FY 11 estimate reflects that
assignment changed to comprehensive inspections.