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Foods Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

Long Term Objective:  Advance Food Safety and Nutrition
 
Measure
FY
Target
Result
213301: Complete review and action on the safety evaluation of direct and indirect food and color additive petitions, within 360 days of receipt. (Output)
2012
90%
October, 2013
2011
80%
October, 2012
2010
70%
October, 2011
2009
60%
100%
(Target Exceeded)
2008
60%
100%
(Target Exceeded)
2007
50%
100%
(Target Exceeded)
 
 Measure
Data Source
Data Validation
213301
CFSAN’s electronic workflow system
The Food Application Regulatory Management (FARM) System is a comprehensive image-based electronic document management, workflow, and reporting automation system. FARM supports electronic processing, review, maintenance, and reporting for food ingredient submissions, including management of food and color additive petitions, Food Contact Notifications (FCNs) (until FY 2008), Generally Recognized as Safe Notices (GRNs) and Biotechnology Consultations. FARM expedites the ingredient review process and subsequent safety decisions. It also helps FDA perform associated activities such as responding and managing correspondence and Freedom of Information requests. FARM also supports industry electronic submission of food ingredient submissions and correspondence in a standard electronic format, further improving efficiencies for industry and FDA. The CFSAN electronic workflow module within FARM provides real-time tracking information on the progress, status, and timeliness of premarket submissions as well as the capability to generate ad-hoc reports including information and statistics on all significant events during the review process.
 
Measure
FY
Target
Result
214101: Number of state, local, and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards. (Outcome)
2012
423 enrolled
December, 2012
2011
398 enrolled
December, 2011
2010
347 enrolled
388 enrolled
(Target Exceeded)
2009
332 enrolled
333 enrolled
(Target Exceeded)
2008
317 enrolled
320 enrolled
(Target Exceeded)
2007
240 enrolled
302 enrolled
(Target Exceeded)
 
 
Measure
Data Source
Data Validation
214101

 
Listing of Jurisdictions Enrolled in the Voluntary National Retail Food Regulatory Program Standards
A listing of jurisdictions enrolled in the Voluntary National Retail Food Regulatory Program Standards can be found on the CFSAN web page  
This listing identifies regulatory agencies that have enrolled in the Voluntary National Retail Food Regulatory Program Standards and have agreed to publish their status as they perform their self assessments, and to develop and implement strategic plans to meet all the Standards. Information is self-reported by the jurisdictions to FDA staff that compiles the information and maintains the listing.
 
Measure
FY
Target
Result
214306:The average number of days to serotype priority pathogens in food (Screening Only). (Output)
 
2012
4 working days
December, 2012
2011
7 working days
December, 2011
2010
N/A
10 working days
2009
N/A
14 working days
(Historical Actual)
2008
N/A
N/A
2007
N/A
N/A
 
Measure
Data Source
Data Validation
214306
Bioplex and
ibis Biosensor systems
CFSAN scientists are developing the means to evaluate and adapt commercially available instruments to develop and validate more rapid, accurate, and transportable tests to stop the spread of food borne illness and cases of chemical contamination. CFSAN scientists are using one such system, known as Bioplex, to rapidly serotype pathogens such as Salmonella. The Bioplex system can serotype 48 different samples in 3 to 4 hours, vastly improving response time in food borne illness outbreaks. CFSAN scientists also are using the ibis Biosensor system to speed the identification of Salmonella, E. coli, and other pathogens, toxins, and chemical contaminants.  When fully deployed, this technology holds the promise of reducing the time to conduct these analyses from 10-14 days to 1-2 days.
 

Measure
FY
Target
Result
214207: The number of assessments/questionnaires to completed to initiate the process of establishing comparability of foreign country food safety systems to that of the U.S. relative to public health outcomes. (Output)
2012
9
December, 2012
2011
5
December, 2011
2010
N/A
N/A
2009
N/A
N/A
2008
N/A
N/A
2007
N/A
N/A
 
Measure
Data Source
Data Validation
214207
FDA Surveillance Systems (e.g., FoodNet, PulseNet, eLEXNET)
 
FDA will conduct administrative assessments of regulatory food safety systems in developed and developing countries to measure their performance against FDA program standards. These assessments will include reviews of inspections, investigations, sample collections and analyses, and enforcement, response, recovery, and outreach activities. The data generated by these assessments will be linked to FDA food safety monitoring activities, and the data will be recorded and analyzed so that the results can be used to enhance the safety of the U.S. food supply. 
 
Measure
FY
Target
Result
214208: Number of consumers who are aware of FDA’s Adverse Event Reporting System for Cosmetics. (Outcome)
2012
+10% over baseline
December, 2012
2011
Set Baseline
December, 2011
2010
N/A
N/A
2009
N/A
N/A
2008
N/A
N/A
2007
N/A
N/A
 
Measure
Data Source
Data Validation
214208
Consumer Focus Group
FDA will use data collected from focus group research to develop FY 2011 baseline. FDA will increase consumer awareness by 10% through research-based and targeted education and outreach campaigns followed by repeat survey/focus groups to determine increase in awareness of FDA’s Adverse Event Reporting System for Cosmetics. 
 
Measure
FY
Target
Result
214201: Number of prior notice import security reviews.  (Output)
2012
80,000
December, 2012
2011
80,000
December, 2011
2010
80,000
81,618
(Target Exceeded)
2009
80,000
81,157
(Target Exceeded)
2008
80,000
80,543
(Target Exceeded)
2007
60,000
84,088
(Target Exceeded)
214202: Number of import food field exams. (Output)
2012
160,000
December, 2012
2011
160,000
December, 2011
2010
140,000
170,392
(Target Exceeded)
2009
120,000
138,916
(Target Exceeded)
2008
85,000
100,718
(Target Exceeded)
2007
71,000
94,743
(Target Exceeded)
214203: Number of Filer Evaluations.  (Output)
2012
1,000
December, 2012
2011
1,000
December, 2011
2010
1,000
1,277
(Target Exceeded)
2009
1,000
1,208
(Target Exceeded)
2008
1,000
1,356
(Target Exceeded)
2007
1,000
1,355
(Target Exceeded)
214204: Number of examinations of FDA refused entries.  (Output)
2012
7,000
December, 2012
2011
7,000
December, 2011
2010
7,000
8,658
(Target Exceeded)
2009
5,000
7,201
(Target Exceeded)
2008
4,000
5,926
(Target Exceeded)
2007
3,000
5,510
(Target Exceeded)
214205: Number of high risk food inspections.  (Output)
2012
8,850
December, 2012
2011
7,800
December, 2011
2010
6,750
6,926
(Target Exceeded)
2009
6,100
6,182
(Target Exceeded)
2008
5,700
6,230
(Target Exceeded)
2007
5,625
6,421
(Target Exceeded)
214303: Convert data from new eLEXNET participating laboratories via automated exchange or convert data from existing manual data streams to automated data exchange.  (Outcome)
2012
5 data exchange additions/conversions
December, 2012
2011
5 data exchange additions/conversions
December, 2011
2010
5 data exchange additions/conversions
5 data entry labs
(Target Met)
2009
5 data exchange additions/conversions
5 data entry labs
(Target Met)
2008
5 data entry labs
11 data entry labs
(Target Exceeded)
214206: Maintain accreditation for ORA labs. (Outcome)
2012
13 labs
December, 2012
2011
13 labs
December, 2011
2010
13 labs
13 labs
(Target Met)
2009
13 labs
13 labs
(Target Met)
2008
13 labs
13 labs
(Target Met)
2007
13 labs
13 labs
(Target Met)
214305: Increase laboratory surge capacity in the event of terrorist attack on the food supply. (Radiological and chemical samples/week). (Outcome)
2012
2,500 rad & 2,100 chem
December, 2012
2011
2,500 rad & 2,100 chem
December, 2011
2010
2,500 rad & 2,100 chem
2,500 rad & 2,100 chem
(Target Met)
2009
2,500 rad & 1,650 chem
2,500 rad & 1,650 chem
(Target Met)
2008
2,500 rad & 1,200 chem
2,500 rad & 1,200 chem
(Target Met)
2007
1,000 rad & 1,200 chem
1,000 rad & 1,200 chem
(Target Met)
 
Measure
Data Source
Data Validation
214201
214202
214203
214204
214205
214303
214206
214305
Field Data Systems
ORA uses two main information technology systems to track and verify field performance goal activities: the Field Accomplishments and Compliance Tracking System (FACTS) and the Operational and Administrative System Import Support (OASIS). FACTS includes data on the number of inspections; field exams; sample collections; laboratory analyses; and, the time spent on each. OASIS, which is coordinated with U.S. Customs and Border Protection, provides data on what FDA regulated products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. FDA is currently developing the Mission Accomplishment and Regulatory Compliance Services (MARCS) system. MARCS will incorporate the capabilities of these two field legacy systems and include additional functionality.
 
Measure
FY
Target
Result
212404: Reduce the incidence of infection caused bykey pathogens commonly transmitted by food: Campylobacter species. (Outcome)
2012
11.9 cases/100,000
March, 2014
2011
12.3 cases/100,000
(New Baselines)*
March, 2013
2010
12.3 cases/100,000
March, 2012
2009
N/A
March, 2011
2008
N/A
12.8 cases/100,000
(Historical Actual)
2007
N/A
12.8 cases/100,000
(Historical Actual)
212405: Reduce the incidence of infection caused by key pathogens commonly transmitted by food:Shiga toxin-producing Escherichia coli O157:H7. (Outcome)
2012
1.08 cases/100,000
March, 2014
2011
1.14 cases/100,000
(New Baselines)*
March, 2013
2010
1.0 cases/100,000
March, 2012
2009
N/A
March, 2011
2008
N/A
1.1 cases/100,000
(Historical Actual)
2007
N/A
1.2 cases/100,000
(Historical Actual)
212406: Reduce the incidence of infection caused by key pathogens commonly transmitted by food: Listeria monocytogenes.   (Outcome)
2012
.28 cases/100,000
March, 2014
2011
.29 cases/100,000
(New Baselines)*
March, 2013
2010
.24 cases/100,000
March, 2012
2009
N/A
March, 2011
2008
N/A
.29 cases/100,000
(Historical Actual)
2007
N/A
.27 cases/100,000
(Historical Actual)
212407: Reduce the incidence of infection caused by key pathogens commonly transmitted by food: Salmonella species. (Outcome)
2012
14.4 cases/100,000
March, 2014
2011
14.8 cases/100,000
(New Baselines)*
March, 2013
2010
6.8 cases/100,000
March, 2012
2009
N/A
March, 2011
2008
N/A
16.2 cases/100,000
(Historical Actual)
2007
N/A
14.9 cases/100,000
(Historical Actual)
* The FY 2010 targets for reducing the incidence of infection caused by Campylobacter species, Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella species were set in the year 2000 as part of the Healthy People 2010 Initiative. The targets for FY 2010 were all calculated as 50% reductions from 1997 baseline incidence levels for these food borne pathogens. The targets for 2010 have not yet been achieved for any of the pathogens included in this objective (though Campylobacter species, E. coli O157:H7 and Listeria monocytogenes are very close, with 48%, 47% and 38% reductions, respectively, as of the 2008 data). Further investigation is needed to identify sources for emerging Salmonella serotypes, since that rate of infection has increased in the past decade.  
The FY 2011 targets start the next decade of targets as part of the Healthy People 2020 Initiative, and are therefore not comparable to the FY 2010 targets. In order to align the new targets for future reductions with more recent data, the baseline data for the FY 2011 targets are from FoodNet data collected from FY 2006 – FY 2008. Consequently, the FY 2011 targets show an increase over the Healthy People 2010 targets due to the new baseline. The Health and Human Services Office of Disease Prevention and Health Promotion (ODPHP) has recently given guidance to the Healthy People work groups on target setting for Healthy People 2020, recommending improvement targets of 10% over the 10-year period.   
 


Measure
Data Source
Data Validation
212404
212405
212406
212407

 
FoodNet
The proactive use of food safety surveillance information and scientific data and tools to prevent illness and injury from foods is a significant focus of FDA. FDA collects data from the FoodNet Data Base to assess and communicate the specific risks associated with specific food products to American consumers and to industry on a routine basis as well as during food borne illness outbreaks to reduce the incidence of infection with key food borne pathogens. CDC’s FoodNet system reports pathogen-specific illness data based on the calendar year, not the fiscal year. Therefore, achievement of the annual targets reported here is evaluated based on the calendar year data, not fiscal year data.
 
Measure
FY
Target
Result
212409: Decrease the rate of Salmonella enteritidis (SE) illness in the population (cases per 100,000). (Outcome)
2012
2.2 cases/100,000
July, 2013
2011
2.3 cases/100,000
July, 2012
2010
N/A
July, 2011
2009
N/A
2.6 cases/100,000 (Historical Actual: average rate of SE illness from 2007 to 2009)
2008
N/A
N/A
2007
N/A
N/A
 


Measure
Data Source
Data Validation
212409

 
CDC/
FoodNet
The modeled rates, which are calculated using an approach based on the approach used in FoodNet’s annual MMWR article to assess changes in rates over time, adjust for the changes in the FoodNet surveillance area over time and for the different baseline disease incidence rates in the various surveillance areas. The modeled rates, therefore, provide a more consistent and accurate framework within which to assess changes in disease rates over time than crude rates. CDC’s FoodNet system reports pathogen-specific illness data based on the calendar year, not the fiscal year. Therefore, achievement of the annual targets reported here is evaluated based on the calendar year data, not fiscal year data.
 
Measure
FY
Target
Result
212408: The number of American consumers who recognize dietary steps that they can take to reduce their risk of chronic disease. (Outcome)
2012
+5% over baseline
December, 2012
2011
Set Baseline
December, 2011
2010
N/A
N/A
2009
N/A
N/A
2008
N/A
N/A
2007
N/A
N/A
 

Measure
Data Source
Data Validation
212408
NHANES
In FY 2011 FDA will use data from NHANES to obtain a baseline assessment of consumer awareness of dietary factors associated with disease risk and their knowledge of and ability to use the nutrition and ingredient information on the food label. FDA will increase consumer awareness through research-based, targeted education and outreach campaigns. FDA will use repeat survey/focus groups to determine increase in awareness and NHANES and USDA data to track changes in food intake patterns and biological responses.

 

Measure
Data Source
Data Validation
212408
NHANES
In FY 2011 FDA will use data from NHANES to obtain a baseline assessment of consumer awareness of dietary factors associated with disease risk and their knowledge of and ability to use the nutrition and ingredient information on the food label. FDA will increase consumer awareness through research-based, targeted education and outreach campaigns. FDA will use repeat survey/focus groups to determine increase in awareness and NHANES and USDA data to track changes in food intake patterns and biological responses.

 

 
1.      Complete review and action on the safety evaluation of direct and indirect food and color additive petitions, within 360 days of receipt. (213301)
 
Context: The likely number of submissions to the food and color additives premarket review program was uncertain for FY 2007 and FY 2008 as a result of statutory triggers in section 409(h) of the FD&C Act that might have dramatically increased the number of submissions to this program. The factors impacting the uncertainty in submission numbers have lessened and performance has stabilized. The FY 2011 target has been increased to 80%, and the FY 2012 target to 90%.
 
Performance: All petitions filed in FY 2010 were completed before the end of FY 2011, exceeding the target for this measure by 40%. This program has consistently exceeded its performance goal each of the last four years. One reason goals have continued to be met is that the actual number of submissions has decreased over that period.
 
2.      Number of state, local, and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards. (214101)
 
Context: Strong and effective regulatory programs at the state, local and tribal level are needed to prevent food borne illness and reduce the occurrence of food borne illness risk factors in retail and foodservice operations. The voluntary use of the Program Standards by a food inspection program reflects a commitment toward continuous improvement and the application of effective risk-based strategies for reducing food borne illness. The success of the FDA National Retail Food Team in increasing enrollment and use of the Standards reflects continued recognition that the Standards help programs improve food safety in food service and retail food establishments. Effective use of the Standards is assured by having enrolled complete program self-assessments to identify program strengths and areas for improvement. The FY 2010 Targets shown in the table above are based on an expectation that additional local jurisdictions will enroll in FY 2010 and make progress toward meeting the Standards as the result, in part, of FY 2009 efforts by FDA to make funds available to jurisdictions who agree to provide FDA with written reports on their progress. With the additional funds that FDA made available to this program in FY 2009, FDA has increased the FY 2011 target to enrolling fifty-one additional jurisdictions to the program. The FY 2012 target has been increased to a total of 423 jurisdictions enrolled. These targeted increases are more modest than previous year’s enrollments in recognition that, in addition to enrolling new jurisdictions, ORA personnel must devote time and resources to assisting the growing number of enrollees with Program Standards implementation. 
 
Performance:   FDA exceeded its FY 2010 target by increasing the number of states, local, and tribal retail food inspection programs enrolled in the FDA Voluntary National Retail Food Regulatory Program Standards by 55 new jurisdictions. This raised the total number of enrolled jurisdictions to 388. FDA has consistently exceeded its targets for this measure for the past 3 years.
 
3.      The average number of days to serotype priority pathogens in food (Screening Only). (214306)
 
Context: FDA Foods Program scientists are evaluating commercially available instrumentation that can be adapted to support the FDA regulatory mission.  CFSAN has advanced two of these technology platforms to Field laboratories, the Bioplex and the ibis Biosensor systems.  The instrumentation is laboratory-based and provides broad-range and strain-specific identification of infectious organisms for multiple applications (clinical and environmental).  The application does not require any prior knowledge of the sample identity and can simultaneously identify and characterize bacterial, viral, fungal, and other infectious organisms.  The technology is extremely high throughput and can analyze thousands of samples a week.  CFSAN has a contract with the developer that has advanced to allow detection of multiple pathogens down to the species level (Escherichia coli O157:H7 may also be determined), CFSAN researchers have field-tested 400 tomato samples to determine the microbiome associated with this commodity.  Further research will evaluate the ability to detect Salmonella genus and sero/subtyping specifics through the next year.  This year, CFSAN will purchase at least two of the systems for placement in other laboratories.  CFSAN researchers will then begin coordinated testing and refinement of the technology for FDA’s needs.  The FY 2011 target for this goal is seven working days and the FY 2012 target is four working days.
 
Performance:   The improvements in sample throughput, along with the high degree of specificity built into this technology, will dramatically improve our response and traceback capabilities. When fully deployed, this technology holds the promise of reducing the time to conduct these analyses from 14 days to 1-2 days.
 
4.      The number of assessments/questionnaires completed to initiate the process of establishing comparability of foreign country food safety systems to that of the U.S. relative to public health outcomes.  (214207)
 
Context:  FDA allows food imports from almost any country and takes on the burden of ensuring the safety of imported foods as they arrive at U.S. ports of entry. Approximately 15-20% of all foods consumed in the U.S. originated from foreign sources: 80% of the seafood and 25-35% of the produce eaten by American consumers are imported. The FDA does not have the resources to inspect all products that reach U.S. border in any given year; however, it is the expectation of American consumers that these imported foods are as safe as foods produced domestically.  In response to this concern, FDA will conduct administrative assessments of regulatory food safety systems in developed and developing countries to measure their performance against FDA program standards. These assessments will include reviews of inspections, investigations, sample collections and analyses, and enforcement, response, recovery, and outreach activities. The data generated by these assessments will be linked to FDA food safety monitoring activities, and the data will be recorded and analyzed so that the results can be used to enhance the safety of the U.S. food supply. In FY 2011, FDA will conduct five additional administrative assessments of foreign regulatory food safety systems, and four additional assessments in FY 2012.
 
Performance: Since this is a new goal, performance data for FY 2011 will not be available until December 2011.
 
5.      Number of consumers who are aware of FDA’s Adverse Event Reporting System for Cosmetics. (214208)
 
Context: There are an increasing number of produces marketed as cosmetics that contain drug or other “active” ingredients. These products are not well-characterized and may pose different and more significant safety issues than traditional cosmetic products. Internet sales are increasing, but the entire extent of this segment of the cosmetic market is not well characterized and problems in traceback to remove unsafe products could be highly significant. Problems may not come immediately to FDA attention because of the significant under-reporting of adverse events associated with cosmetics. FDA feels that increasing consumer awareness of FDA’s Adverse Event reporting System for cosmetics would be a major step in reducing this important public health risk.
 
Performance: Baseline data will be developed in FY 2011 through focus group research. FDA will conduct research-based and targeted education and outreach campaigns followed by repeat survey/focus groups to determine increase in awareness of FDA’s Adverse Event Reporting System for Cosmetics. 
 
6.      Number of prior notice import security reviews.  (214201)
 
Context:   FDA’s Prior Notice Center (PNC) was established in response to regulations promulgated in conjunction with the Public Health Security and Bioterrorism Preparedness Act of 2002 (BTA). Its mission is to identify imported food and feed products that may be intentionally contaminated with biological, chemical, or radiological agents, and/or to identify those that may pose a significant health risk to the American public and prevent them from entering into the U.S. food supply. FDA will continue to focus much of its PNC resources on intensive prior notice security reviews of imported food/feed shipments that pose the highest potential bioterrorism risks to the U.S. consumer. Every (100%) prior notice is electronically screened and targeted and all those identified as high risk receive an intensive security review. The total number of intensive prior notice security reviews conducted by the PNC is impacted by current intelligence factors, targeting priorities, and the number of high risk shipments being imported. Therefore, this total may increase or decrease in future years. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance:  During FY 2010, FDA received 10,039,557 prior notice submissions on which the PNC conducted 81,681 intensive prior notice security reviews of  import security reviews(exceeding the performance target of 80,000 reviews) to identify and intercept potentially contaminated food and animal food/feed products before they entered the U.S. A total of1,340 shipments were the subject of PNC compliance actions for prior notice or food facility registration violations, which was more than 1.5 times the total number of PN related actions from the previous fiscal year.  The PNC operations actively strengthen the U.S. food supply and provide early food security/defense driven targeting and risk assessments to detect food shipments that pose or may pose a potential terrorist threat.  In addition, the PNC responded to more than21,000 phone and e-mail inquiries, and conducted over826 informed compliance calls to the import trade in order to facilitate better compliance with the submission of accurate, timely prior notice information.
 
7.      Number of import food field exams on products with suspect histories. (214202)
 
Context:   The volume of imported food shipments has been rising steadily in recent years and this trend is likely to continue. FDA reviewed approximately 9.8 million line entries of imported food out of an estimated 20.0 million lines of FDA regulated products in FY 2009.  In FY 2010, FDA expects approximately 10.1 million line entries of imported food within a total of more than 23.2 million lines of FDA regulated entries. To manage this ever-increasing volume of imports, FDA uses risk management strategies to achieve the greatest food protection with available resources. While the percentage of imports physically examined may decline as imports continue their explosive growth, the exams that ORA conducts are more targeted and more effective than ever before. ORA continues to think that the best approach to improve the safety and security of food import lines is to devote resources to expand targeting and follow through on potentially high-risk import entries rather than simply increasing the percentage of food import lines given a field exam. In FY 2009 through FY 2011 FDA increased the target by 20,000 exams each year. In FY 2012, the target is being maintained at the FY 2011 level of 160,000 field exams.
 
Performance: In FY 2010, FDA exceeded the target of 140,000 by completing 170,392 imported food lines examined. Explanation of why this goal was significantly exceeded: With the increase in funding, FDA was able to bring on a significant number of new investigators. Field exams play a significant role in new investigator training which resulted in exceeding the goal. Since new investigators were using these for training purposes, more resources than would normally go toward this target were utilized. Once investigators are fully trained, they will have other duties in addition to examining imported food lines. In FY 2011, FDA will retain our projected target of 160,000 due to the implementation of new field exam risk targeting procedures. The field exams will be more involved as a result of the new procedures but will result in a more focused public health outcome.
 
8.      Number of Filer Evaluations of import filers.   (214203)
 
Context: The Food and Drug Administration (FDA) receives electronic import entry data for assessing the admissibility of regulated imported articles. The accuracy of these data directly relates to the level of confidence that American consumers can expect in the quality, safety and compliance of imported articles subject to FDA’s jurisdiction. Entry data affects FDA’s determination of the labeling, quality, safety, approval status, and efficacy of FDA-regulated import articles. FDA uses an electronic entry screening system, Operational and Administrative System for Import Support (OASIS), to screen import entry data transmitted by import filers. Filers who fail an evaluation must implement a Corrective Action Plan and pass a tightened evaluation. This protects public health by ensuring reporting compliance for imported articles that FDA regulates. FDA will continue to develop and apply methods to evaluate filer accuracy that are consistent with evolving security and import regulation practices. The FY 2012 target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA exceeded this goal of 1,000 by performing 1,277 filer evaluations. This goal is an agency-wide goal and performance data includes activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program.
 
9.      Number of examinations of FDA refused entries. (214204)
 
Context:  FDA is responsible for the protection of the U.S. public regarding foods, drugs, devices, electronic products and cosmetics. This protection includes refusing entry of products into the U.S. when they are deemed violative and assuring these violative products are either destroyed or exported and do not enter into domestic commerce. Although primary responsibility for supervising destruction or exportation rests with the Bureau of Customs and Border Protection (CBP), FDA monitors the disposition of refused shipments and maintains an open file until the product is exported or destroyed. In cooperation with CBP, FDA will, at times, supervise destruction or examine products prior to export in order to assure that the refused product is actually exported. This performance goal only counts FDA supervised destruction or exportation of refused entries. In other cases FDA relies on notification from CBP that the refused products have been destroyed or exported. The FY 2009 target was increased to 5,000 examinations to better reflect the recent historical actuals for this goal. In FY 2010, the target was again increased to 7,000 to better reflect actual accomplishments.  The FY 2012 target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA exceeded this goal of 7,000 by performing 8,658 examinations of FDA refused entries as they were delivered for exportation to assure that the products refused by FDA were exported. This goal is an agency wide goal and performance data includes activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program.  Explanation of why this goal was significantly exceeded: Examinations of refused entries are a function of refusals each year. More refusals result in a larger amount of verifications. In FY 2010, there was an increased number of refusals which caused the examinations to increase as well. In FY 2012, the performance target will continue to be maintained at the FY 2011 level because there is no way to predict the number of refusals in a given year. 
 
10. Number of high risk food inspections.   (214205)
 
Context: High risk food establishments are those that produce, prepare, pack or hold foods that are at high potential risk of microbiological or chemical contamination due to the nature of the foods or the processes used to produce them.  This category also includes foods produced for at risk populations such as infants and the immunocompromised.  The Field intends to inspect such establishments annually, or more frequently on a “for cause” basis.  The FDA inventory of high-risk establishments is dynamic and subject to change.   For example, firms go out of business, new high-risk food firms enter the market, or the definition of high risk evolves based on new information on food hazards.  High-risk establishment inspection frequencies vary depending on the products produced and the nature of the establishment.  Inspection priorities may be based on a firm’s compliance history or sample results. The FY 2009 target was increased to 6,100 inspections of high-risk food establishments to better reflect the recent historical actuals for this goal. For FY 2010, the target was increased to 6,750 to reflect the FY 2009 Appropriations.  In FY 2011, the target is being increased by 1,050 inspections for a new target of 7,800 inspections. In FY 2012, the target is being increased to 8,850 inspections.
 
Performance: In FY 2010, FDA exceeded this goal of 6,750 by performing 6,926 high-risk foreign and domestic food inspections.
 
11. Convert data from new eLEXNET participating laboratories via automated exchange or convert data from existing manual data streams to automated data exchange. (214303)
 
Context: The electronic Laboratory Exchange Network (eLEXNET) is a seamless, integrated, secure network that allows multiple agencies (federal, State and local health laboratories on a voluntary basis) engaged in food safety activities to compare, communicate, and coordinate findings of laboratory analyses. eLEXNET enables health officials to assess risks, analyze trends and provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods. As of the end of FY 2009, there are 224 total laboratories currently participating in eLEXNET overall.  These labs include segments of a wide variety of food safety organizations on Federal, Military, State, and Local government levels.  These labs also span the agricultural, environmental, public health, veterinary, and diagnostic disciplines as well.  Of the 224 participating laboratories in all 50 states, 144 are actively entering or submitting data.  There are 44 labs among them that are fully automated via Data Exchange and transfer their LIMS sample data on a regular, ongoing basis.  The 100 other remaining laboratories enter data in eLEXNET through manual data entry.  The overall goal of the FDA's eLEXNET program is to continue to integrate those labs participating in eLEXNET via Data Exchange and to identify new labs to expand our membership.  Through continued expansion of our membership base and active data sources, the eLEXNET program will continue to serve as a key collaborative tool for food surveillance entities nationwide. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA met its performance goal by fully automating electronic data exchange between five new labs and FDA's eLEXNET (electronic Laboratory Exchange Network).  This makes the total number of automated data exchange participant labs to 44. The automated data transfer does not require any human intervention and is completely maintenance free unless there is a change in the lab environment.
 
12. Establish and maintain accreditation for ORA labs. (214206)
 
Context: FDA is a science-based agency that depends on its regulatory laboratories for timely, accurate, and defensible analytical results in meeting its consumer protection mandate. Our laboratories have enjoyed a long history of excellence in science upon which the agency has built its reputation as a leading regulatory authority in the world health community. Accreditation of laboratory quality management systems provides a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science. Such accreditations allow FDA to maintain its reputation as a source of scientifically sound information and guidance both domestically and in the international arena.  In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA met this laboratory accreditation goal. FDA maintained accreditation for 13 laboratories: Denver District Lab, Forensic Chemistry Center, Arkansas Regional Lab, Pacific Regional Lab Northwest, San Francisco District Lab, Winchester Engineering and Analytical Center, New York Regional Lab, Southeast Regional Lab, San Juan District Lab, Detroit District Lab, Pacific Regional Lab Southwest, and Kansas City District Lab. All ORA Field Laboratories are accredited to ISO 17025 by the American Association for Laboratory Accreditation. FCC is accredited by the ASCLD (American Society of Crime Laboratory Directors).
 
13. Increase laboratory surge capacity in the event of terrorist attack on the food supply.   (Radiological and chemical samples/week)   (214305)    
 
Context: A critical component of controlling threats from deliberate food-borne contamination is the ability to rapidly test large numbers of samples of potentially contaminated foods for the presence of contaminants. To address the need for this surge capacity, The Food Emergency Response Network (FERN), a joint effort between USDA/FSIS and HHS/FDA, was created. FERN is a nationwide laboratory network that integrates existing federal and State food testing laboratory resources capable of analyzing foods for agents of concern in order to prevent, prepare for, and respond to national emergencies involving unsafe food products. Improvements in surge capacity will have public health value even in non-deliberate food contamination by assisting FDA in identifying and removing contaminated food products from the marketplace as soon as possible in order to protect the public health and mitigate disruption in the U.S. food supply chain. FDA awards FERN Cooperative Agreements for chemistry and radiological FERN labs to the States. After receiving the funding, State FERN laboratories can take up to one year to reach full capacity due to the need for training and testing to ensure confidence in the laboratory results. As a result, labs funded in one fiscal year will not show surge capacity until the following year. With FY 2008 Food Protection increases, ORA added three additional FERN chemical labs in FY 2008 which increased the surge capacity in FY 2009 to 1,650 chemical samples per week. With the FY 2009 Appropriation, ORA added three additional FERN chemical labs in FY 2009 which increased the surge capacity to 2,100 chemical samples per week.  In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA met this performance goal surge capacity target of 2,100 chem samples per week. FDA also maintained the surge capacity for 2,500 rad samples per week. The FERN laboratories increasingly provide critical analytical surge capacity during food emergency events. An FDA assignment ("Surveillance, Inspection and Sample Collection and Analyses of Products Related to the Salmonella St. Paul Investigation" issued by ORA/CFSAN) directed samples to the FERN labs in the Salmonella outbreak in peppers, with 290 samples tested. FERN Chemistry laboratories participated in the #09-06 CFSAN Melamine Import Assignment (2008-2009), assisting FDA in the analysis of milk and protein samples, analyzing 340 samples. These FERN labs were a key factor in clearing an FDA sample backlog, which arose due to very high collection rates. FERN laboratories also participated in the FDA surveillance assignment for the political conventions. All of these efforts contribute to increasing FDA’s capacity to analyze food samples relative to biological, chemical or radiological acts of terrorism and enhance the food safety and security efforts of state, local, and tribal regulatory bodies.
14. Reduce the incidence of infection caused by key pathogens commonly transmitted by food. (212404 – 212407)
 
Context: The Nation’s challenges to food protection are increasing as consumers buy food from around the globe. FDA’s Foods Program features a science and risk-based approach of prevention, intervention, and response to ensure the safety of domestic as well as imported foods. Federal, Tribal, and State partners use a combination of research, inspections, surveillance, regulation and guidance, standardization and education as strategies to improve food safety. The proactive use of food safety surveillance information and scientific data and tools to prevent illness and injury from foods is a significant focus of FDA. FDA collects data from the FoodNet Data Base to assess and communicate the specific risks associated with specific food products to American consumers and to industry on a routine basis as well as during foodborne illness outbreaks to reduce the incidence of infection with key foodborne pathogens. Foodborne illness surveillance information is also used to determine what additional food safety strategies are needed and to measure the effectiveness of interventions over time.
 
Performance: The FY 2010 targets for reducing the incidence of infection caused by Campylobacter species, Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella species were set in the year 2000 as part of the Healthy People 2010 Initiative. The targets for FY 2010 were all calculated as 50% reductions from 1997 baseline incidence levels for these foodborne pathogens. The targets for 2010 have not yet been achieved for any of the pathogens included in this objective (though Campylobacter species, E. coli O157:H7 and Listeria monocytogenes are very close, with 48%, 47% and 38% reductions, respectively, as of the 2008 data). Further investigation is needed to identify sources for emerging Salmonella serotypes, since that rate of infection has increased in the past decade. The FY 2011 targets start the next decade of targets as part of the Healthy People 2020 Initiative, and are therefore not comparable to the FY 2010 targets. In order to align the new targets for future reductions with more recent data, the baseline data for the FY 2011 targets is from FoodNet data collected from FY 2006 – FY 2008. Consequently, the FY 2011 targets show an increase over the Healthy People 2010 targets due to the new baseline. The Health and Human Services Office of Disease Prevention and Health Promotion (ODPHP) has recently given guidance to the Healthy People work groups on target setting for Healthy People 2020, recommending improvement targets of 10% over the 10-year period. 
 
15. Decrease the rate of Salmonella enteritidis (SE) illness in the population (cases per 100,000). (212409)
 
Context: A regulation to reduce illnesses from Salmonella enteritidis (SE)has recently been promulgated by the Food and Drug Administration (FDA). FDA's final egg rule, "Prevention of Salmonella enteritidis in Shell Eggs During Production, Storage and Transportation", was published on July 9, 2009. This rule requires shell egg producers to implement controls to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation. The regulation also requires egg producers to maintain records concerning their compliance with the egg rule and to register with FDA. The final rule is expected to reduce SE-associated illnesses and deaths by reducing the likelihood that shell eggs are contaminated with SE. The compliance date is July 9, 2010 for egg producers with 50,000 or more laying hens, and July 9, 2012 for producers with fewer than 50,000 but at least 3,000 laying hens. For persons who must comply with the refrigeration requirements, the compliance date is July 9, 2010. FDA will implement the new regulation by:
  • Developing guidance to provide the regulated community with specific information about how to comply with the rule;
  • Training investigators so they have the information they need to enforce the regulation;
  • Conducting inspections to ensure compliance with the regulation; and
  • Using State Contracts to extend the reach of FDA investigators to ensure compliance.
An increase of illnesses from Salmonella enteritidis in shell eggs was detected by CDC in spring of 2010. Investigation revealed that many of these illnesses could be traced back to shell eggs. The impact of this increased rate of illnesses in 2010 on the ability to meet the goal in 2011 is unknown. The FY 2011 target is 2.3 cases/100,000 and the FY 2012 target is 2.2 cases/100,000.
 
Performance: Reducing the rate of food-borne illness is an important outcome goal.  Preventing Salmonella illness depends not only on oversight actions by the regulatory agencies, but also on information gathered and decisions made throughout the entire farm-to-table process by industry and consumers. The rate of illness will also depend on actions taken by all these stakeholders to detect and respond to outbreaks when they do occur. In other words, if an outbreak is detected early and effectively responded to quickly, fewer people will get sick. The regulatory role is shared by local, state and federal agencies. In addition, state and local public health agencies and CDC play a critical role with their data collection and their ability to link public health impacts with specific food commodities. Clearly, the accomplishment of any food-borne disease reduction goal is dependent on efforts made by many stakeholders. CDC’s FoodNet system reports pathogen-specific illness data based on the calendar year, not the fiscal year. Therefore, achievement of the annual targets reported is evaluated based on the calendar year data, not fiscal year data. CY 2010 data will be available in July 2011.
 
16. The number of American consumers who recognize dietary steps that they can take to reduce their risk of chronic disease. (212408)
 
Context: One of the most important strategies in assuring that citizens lead long, healthy lives and minimize the likelihood of chronic disease is the use of science-based nutrition information to make wise choices about the foods they consume. The costs to inform, educate, and motivate consumers to these dietary choices are small compared to the costs to society of dealing with the chronic illnesses whose prevalence is based on a poor diet. The public health focus of this initiative is to expand and enhance food-labeling programs, education, outreach, and research to enable American consumers to make more informed and healthful food choices, maintain health, and reduce the risk of chronic diseases such as type 2 diabetes, cardiovascular disease, and obesity.
 
Performance: CFSAN will develop effective dietary guidance messages, education, and outreach programs. This will support efforts to increase consumer recognition of dietary factors that are associated with chronic disease risk and the steps they can take to reduce risk. The target for this item was shifted forward a year due to the 2010 Census and OMB moratorium on survey/focus groups, etc. CFSAN will set the baseline in FY 2011.

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