U.S. Food and
Drug Administration
Performance Plan
2002
2.2 FOODS
2.2.2 Program Description, Context, and Summary of Performance
Total Program Resources:
|
FY
2003
Current Estimate |
FY
2002
Current Estimate |
FY
2001
Actual |
FY
2000
Actual |
FY
1999
Actual |
Total
($000) |
412,097
|
404,599 |
287,504 |
279,704 |
235,168 |
The FDA's Foods Program is responsible for ensuring a safe, nutritious, wholesome, and honestly labeled food supply and safe and properly labeled cosmetics for the American public.
FDA regulates all food except meat, poultry, and frozen and dried eggs, which are regulated by the U.S. Department of Agriculture. The Foods Program accomplishes its mission by: setting standards and developing regulations for the food industry; taking timely and appropriate action on new food ingredients and dietary supplements before they go on the market to ensure their safety; conducting research to provide the necessary basis for its regulatory decisions; assuring the quality of foods, food ingredients, dietary supplements and cosmetics that are available on the market; identifying food-related health hazards; taking corrective action to reduce human exposure to these hazards and the possibility of food-related illnesses and injuries; and expanding food safety education and training for consumers and industry.
As we enter the 21st Century, trends in the food industry promise better nutrition, greater economies and wider choices for the U.S. consumer than ever before. To illustrate:
- The biotechnology explosion has opened new frontiers in product development,
thus providing us the ability to genetically alter foods to make produce more
resistant to disease, add desirable consumption characteristics to the foods,
and to prolong shelf life.
- The volume and diversity of imported foods has risen dramatically over the
last few decades, and foods once considered exotic are now found throughout
the U.S.
- The globalization of the food supply means that foods we consume are being
produced by a much larger number of source countries.
- The dietary supplements industry has grown dramatically, as has consumption
of dietary supplements.
Each of these developments also presents regulatory challenges for FDA. The Agency's job is to give consumers the confidence to enjoy the benefits of these expanded food choices.
On January 3, 2000, CFSAN set forth its overall dietary supplement strategy. This strategy is built on the foundation of law and science. This strategy establishes a clear program goal to accomplish, by the year 2010, having a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
FDA will continue to seek additional resources for initiatives identified in this plan through the established budget process. The success of this strategy will not only depend on adequate funding levels, but also on FDA's new and continued partnerships with other governmental agencies, academia, health professionals, industry, and consumers. FDA will continue its outreach to stakeholders to enhance two-way dialogue, establish stronger working relationships, leverage resources, and communicate dietary supplement information.
On July 6, 2000, FDA issued an import alert for bulk or finished dietary supplements and other products that may contain aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin. Products containing aristolochic acid cause renal damage and can cause or contribute to renal failure. Its nephrotoxic potential has been shown in animals and has been demonstrated in humans in both case reports and in at least one human clinical study. Products that contain a large amount of aristolochic acid have been documented to result in the rapid onset of acute toxicity symptoms. Outbreaks of aristolochic acid-associated renal failure have been reported in several countries, including Belgium, France, Spain, Japan, Australia, and the United Kingdom. Recent chemical analysis of currently marketed Chinese herbal medicines and dietary supplements by British and Canadian health authorities identified products that contained aristolochic acid. However, the labels of the products did not indicate that they contained an ingredient known to contain aristolochic acid. This indicates that there is a potential for dietary supplements and some traditional herbal medicines to inadvertently be formulated using aristolochic-acid containing ingredients. FDA is aware that these and similar products are being sold in the United States.
Two strategic goals define the Foods Program's approaches for meeting the challenges of the 21st century:
- Provide consumers quicker access to new food ingredients, bioengineered
foods, and dietary supplements, while assuring their safety.
- Reduce the health risks associated with food and cosmetic products
by preventing human exposure to hazards, monitoring product quality and correcting
problems that are identified.
By striving toward these two goals, FDA will assure the quality of food ingredients, dietary supplements, bioengineered foods, and cosmetic products both before and after they go on the market. Since only a limited category of food products is subject to FDA premarket approval, FDA relies heavily on its postmarket surveillance and compliance activities to assure the safety and quality of the products it regulates.
2.2.2 Strategic Goals
Strategic Goal 1:
Provide consumers quicker access
to new food ingredients, bioengineered
foods, and dietary supplements, while
assuring their safety.
A. Strategic Goal Explanation
The Foods premarket review program focuses on food and color additive petitions, dietary supplements, substances that are generally recognized as safe (GRAS), and bioengineered foods. Under the FD&C Act, FDA must review the safety of food and color additives before food manufacturers and distributors can market them. To initiate this review, sponsors are required to submit a petition or notification that includes appropriate test data to demonstrate the safety of the intended use of the substance. Under the Dietary Supplement Health Education Act (DSHEA), industry is required to notify the Agency of any "new ingredient" for a dietary supplement. DSHEA requires that companies make certain submissions to FDA when health claims are made for dietary supplements and that companies provide a scientific basis for the safety of new dietary ingredients. The Agency must respond to the sponsor's notification with a decision within 75 days. The Agency also has a notification program for substances that are GRAS. Finally, the Agency consults with developers of foods derived from bioengineered plants to ensure that all safety and regulatory questions are resolved prior to marketing, and has proposed a mandatory premarket notification program for these foods.
The Food Program's key challenge in the premarket area is to expedite review of new food products without jeopardizing public safety. To provide the U.S. public quicker access to new food ingredients and dietary supplements, FDA will:
- Work closely with petitioners, before and after they file premarket approval
applications, to avoid or quickly resolve problems
- Simplify and expedite the food and color additive petition review process
* Make timely decisions on new food and color additive petitions (Performance
Goal 1-11001)
- Respond to premarket notifications for food contact substances within the
statutory time frame (Performance Goal 3-11034)
- Respond to dietary supplement notifications within 75 days (Performance
Goal 2-11025)
- Give priority to those additives that are intended to decrease the incidence
of foodborne illness
- Improve management systems
- Recruit and hire reviewer-scientists (including professionals with the special
skills to evaluate dietary supplements and food and color additives, such
as medical doctors, consumer safety officers, chemists, botanists, herbalists
and toxicologists)
- Conduct specific research to develop science-based policies for effective
regulation and effectively communicate any risks associated with bioengineered
foods.
- Use contract personnel for some petition reviews
B. Summary of Performance Goals
Performance Goals |
Targets |
Actual Performance |
Reference
|
1.
Complete the safety evaluation
of 65 percent of the number of
food and color additive petitions
that were under review for more
than 360 days at the beginning
of the Fiscal Year.
(11001) |
FY
03: 65 percent
FY 02: 60 percent
FY 01: 50 percent
FY 00: 40 percent
FY 99: 30 percent |
FY
03:
FY 02:
FY 01: 10/02
FY 00: 91 percent
FY 99: 77 percent |
|
2.
Respond to 95 percent of notifications
for dietary supplements containing
"new dietary ingredients"
within 75 days. (11025) |
FY
03: 95 percent
FY 02: 95 percent
FY 01: 90 percent
FY 00: 90 percent
FY 99: N/A |
FY
03:
FY 02:
FY 01: 100 percent
FY 00: 100 percent
FY 99: 100 percent |
|
3.
Complete processing of 80 percent
of GRAS notifications within
180 days. (11003)
|
FY
03: N/A
FY 02: N/A
FY 01: 80 percent
FY 00: Finalize GRAS Rule late
in year or early 01
FY 99: Finalize the rulemaking
creating a premarket notification
process for independent GRAS
determinations. |
FY
03:
FY 02:
FY 01: 06/02
FY 00: made progress toward finalizing
GRAS rule
FY 99: rule not completed, no
measurement |
|
4.
Review 95 percent of premarket
notifications for food contact
substances in the receipt cohort
of FY 2002 within the statutory
time limit (120 days). (11034) |
FY
03: 95 percent
FY 02: 95 percent
FY 01: N/A
FY 00: N/A |
FY
03:
FY 02:
FY 01: 3/02
FY 00: 99 percent |
|
5.
Publish a final rule to require
premarket notification for bioengineered
foods. (11035) |
FY
03: Publish final rule
FY 02: N/A
FY 01: N/A
FY 00: N/A |
FY
03:
FY 02:
FY 01: N/A
FY 00: N/A |
|
TOTAL
FUNDING:
($000) |
FY
2003: 57,693
FY 2002: 56,643
FY 2001: 39,850
FY 2000: 39,661
FY 1999: 25,196 |
|
|
C. Goal-by-Goal Presentation of Performance
1. Complete the safety evaluation of 65 percent of the number of food
and color additive petitions that were under review for more than 360 days at
the beginning of the Fiscal Year. (11001)
- Context of Goal:
In this goal, a first action is
defined as a review of all parts
of a petition, followed by issuance
of a "not approvable" letter, or
publication of a response in the
Federal Register, if appropriate.
"Time to first action" is not the
same as meeting the statutory time
frame (i.e., 90 days, extendable
to 180 days). It is widely recognized
that meeting the current statutory
time frame is an unrealistic goal
for all food and color additive
petitions, especially the more
complex ones. The impracticability
of the current time frame was acknowledged
in the report from the June 1995
House hearing, and a recommendation
to change the time frame to '360
days of receipt' was included in
the Agency's testimony before the
House Committee on Government Reform
and Oversight in 1996.
Since the 1995 and 1996 hearings,
the FDAMA established a notification
process for food contact substances.
The premarket notification program
began to fully operate on January
18, 2000. Several factors will
influence future performance on
this goal of completing the safety
evaluation of 65 percent of food
and color additive petitions within
360 days. The most important of
these factors is the implementation
of the new premarket notification
process. With the full implementation
of the premarket notification program,
many of the simpler food additive
petitions that could have been
completed within 360 days are being
filed under the notification program,
thus decreasing the workload for
this goal. However, since the remaining
petitions are likely to be more
complex and take more time to review,
the Agency performance on this
goal may decline initially. Once
the notification and the petition
review processes are well established,
FDA expects performance on this
goal to increase substantially
toward full performance in succeeding
years beginning in FY 2002.
- Data Sources: CFSAN's electronic workflow system
- Performance: In FY 2000, FDA exceeded its goal of completing
the review of 40 percent, respectively, of food and color additive petitions
with 360 days. The high performance figures in 1999 and 2000 do not presage
similar numbers in later years. This is primarily because Congress passed,
under the FDA Modernization Act of 1997, and implemented in FY 2000, the Food
Contact Substance Premarket Notification Program. As a result, we are now
receiving far fewer petitions in total than in previous years, and those that
we do receive are for direct food additive uses of greater potential public
health significance; in general, these take more time and effort per petition
to complete. In addition, as the new PMN program was being implemented, many
pending petitions for food contact materials were withdrawn, leading to "completed
actions" on many petitions. This artifact led to the increased performance
figures for the receipt cohorts of FY 1999 and FY 2000. This is, however,
a one-time phenomenon. We have done a careful analysis of these trends in
recent years. Based on all available data, including receipt of far fewer
(but generally far more labor intensive) petitions than in previous years,
we project that completing review of 65 percent of food and color additive
petitions in 360 days for the 2002 receipt cohort is a fair and challenging
level of performance. FY 2001 data is expected in October 2002.
2. Respond to 95 percent of notifications for dietary supplements
containing "new dietary ingredients" within 75 days. (11025)
- Context of Goal: Within 75 days, FDA reviews premarket
notifications for new dietary ingredients (NDI) of dietary supplements. The
Agency anticipates that in the future these notifications will become more
complex and that the volume of such notifications submitted to the FDA will
increase. Nevertheless, the Agency has increased its review goal target from
90 percent to 95 percent for both FY 2002 and FY 2003. Since the Agency does
not know precisely what the workload will be in any given year, the 95 percent
target is considered full performance the next two fiscal years.
- Data Sources: CFSAN's Correspondence Tracking System and
manual tracking
- Performance: Since the beginning of this premarket notification
program, FDA has completed 100 percent of its reviews of NDI notifications
within the 75-day deadline. Due to the overlapping nature of a 75-day period,
a notification review may be completed during the same or following fiscal
year in which it was received. In addition, a notification may be received
prior to the fiscal year in which the review was completed. Based upon this
scenario, the following data represents the actual number of NDI notification
reviews completed within the stated fiscal year: 20 in FY 1998; 23 in FY 1999;
25 in FY 2000; and 22 in FY 2001.
3. Complete processing of 85 percent of GRAS notifications within 180
days. (11003)
- Context of Goal: (Goal Dropped for FY 2002 and 2003). GRAS
notification is a new program and the final rule creating a premarket notification
process for independent GRAS determinations is planned for publication soon.
Through the GRAS notification process, the FDA seeks to exempt certain substances
that are generally recognized as safe from the premarket review process and
make food products containing these substances available on the market more
quickly. Under the proposed notification procedure, FDA intends to evaluate
whether the submitted notice provides sufficient basis for a GRAS determination
and whether information in the notice or otherwise available to FDA raises
issues that lead the Agency to questions whether use of the substance is GRAS.
The proposed notification procedure would allow FDA to direct its resources
to questions about GRAS status that are a priority with respect to public
health protection. FDA performance will be measured based on the timeframe
established by the final rule. Completion of this goal represents movement
from a time and resource intensive review of GRAS affirmation petitions to
a streamlined and expeditious review process. The rule replaces the existing
process used by sponsors to notify FDA of their independent GRAS determinations.
- Data Sources: CFSAN's electronic workflow system; Internal
Office of Pre-Market Approval database.
- Performance: FY 2001 Performance data will be available
in June 2002. CFSAN evaluated a cohort of GRAS notices (GRNs) received in
FY 2000. For this cohort, CFSAN responded to 59 percent of GRAS notices received
within 180 days. A total of 27 GRNs were received in FY 2000; 16 of 27 (59
percent) were completed in less than 180 days; 4 of 27 (15 percent) were completed
in less than 220 days. The nature of the Agency's response was as follows:
FDA had no questions - 19 of 27 (70 percent); notice that did not provide
a basis for GRAS - 4 of 27 (15 percent); notifier stopped process - 3 of 27
(11 percent); and one GRN is still pending. In FY 2000, FDA made substantial
progress toward the goal of publishing a final rule for this program. However,
due to resource restraints and competing priorities the rule was not finalized.
4. Review 95 percent of premarket notifications for food contact substances
in the receipt cohort of FY 2002 within the statutory time limit (120 days).
(11034)
- Context of Goal: The data for FY 2001 will be available
March 2002. As provided in the Food and Drug Administration Modernization
Act (FDAMA), the Agency was mandated to establish a premarket notification
program for food contact substances as a vehicle to re-inventing the premarket
review process for food and color additives. The Congress appropriated resources
in FY 2000 to fully fund this Program, and the first notifications became
effective in March 2000. The statute provides that a food contact substance
notification shall become effective (i.e., the food contact substance may
be lawfully marketed) 120 days after receipt unless the Agency objects that
the use of the food contact substance has not been shown to be safe. Thus,
to ensure that unsafe food contact substances do not enter the marketplace,
the program goal is to review all notifications within 120 days. Doing this
will require that adequate resources continue to be provided for this program.
- Data Sources: CFSAN's electronic workflow system; Internal
Office of Pre-Market Approval database.
- Performance: In FY 2000, the Agency completed review of
82 of 83 notifications for food contact substances within 120 days. FY 2001
data is expected in March 2002.
Publish a final rule to require premarket notification for bioengineered
foods. (11035)
- Context of Goal: Currently, FDA has a voluntary process
through which companies marketing bioengineered foods consult with the Agency
on safety and other regulatory issues. FDA believes no safety problem exists
with any genetically engineered food that is currently on the market. However,
as part of a government-wide initiative to strengthen science-based regulation
and improve public access to information about bioengineered foods, FDA has
proposed a regulation that, if finalized, would require developers of bioengineered
foods to notify the agency 120 days prior to marketing a new bioengineered
food (66 FR 4706; January 18, 2001). As part of the proposed rule, FDA would
make available, through an Internet-based electronic reading room, the information
provided by the developer to FDA. FDA also would update its food biotechnology
Internet site to make more information available to the public, including
FDA's memoranda of evaluation and letters to sponsors of bioengineered foods.
FDA took this action because it expects that biotechnology methods are likely
to be used to an increasingly greater extent by plant breeders, and because
it expects that the products of this technology are likely in some cases to
present more complex safety and regulatory issues than has been seen to date.
- Data Sources: Federal Register; FDA's Internet site
- Performance: FDA already has issued a proposed rule to
require premarket notification for bioengineered foods. The proposed rule,
if finalized, will ensure that FDA has the appropriate amount of information
about bioengineered foods to help to ensure that all market entry decisions
by the industry are made consistently and in full compliance with the law.
The proposed action will permit the agency to assess on an ongoing basis whether
plant-derived bioengineered foods comply with the standards of the Federal
Food, Drug, and Cosmetic Act. FDA also has already updated its Internet site
to provide more information about bioengineered foods that the agency has
evaluated under the current, voluntary process. As of March 2001, FDA has
received more than 40,000 comments on the proposed rule. In order to complete
the goal, FDA must analyze the comments and determine whether the complete
administrative record of the rulemaking (including the comments) supports
the requirement as proposed. If the complete administrative record supports
the issuance of a final rule, FDA intends to publish the final rule by the
end of FY 2003.
Strategic Goal 2:
Reduce the health risks associated
with food and cosmetic products by
preventing human exposure to hazards,
monitoring product quality and correcting
problems that are identified.
A. Strategic Goal Explanation
This strategic goal emphasizes three areas of effort-Preventative Control Systems, Compliance Monitoring, and Adverse Event Reporting (AER)-that FDA uses to assure the safety of food and cosmetic products from the point of production through consumption or use by consumers.
Preventative Control Systems
Given the increasing complexity of food safety issues, the most effective strategy for reducing foodborne illness and mortality is to prevent the pathogenic contamination of food through the implementation of food safety standards at all points along the food production chain both in the United States and in foreign countries. FDA's prevention strategies for achieving its objective of reducing health risks associated with food and cosmetic products emphasize:
- Working with states and the food industry to develop and implement food
production and preventive control systems that are appropriate to specific
product hazard combinations and to establish regulatory processes and systems
to more effectively and efficiently monitor the food supply
- Getting more states to adopt the model Food Code, which provides standards
and guidance on food safety, sanitation, and fair dealing that may be uniformly
adopted by the retail food industry
- Working with foreign countries exporting food and cosmetic products to the
U.S. to ensure the implementation of comparable safety standards
- Conducting consumer education and industry education aimed at disease prevention
Compliance Monitoring
Compliance monitoring is a critical component of food safety assurance during and after production and through the commercial distribution stage. FDA has the statutory authority to inspect establishments, examine or analyze samples, and conduct investigations to determine whether product safety and quality standards are met at each stage of commercial food and cosmetic production and distribution. The Agency accomplishes its safety assurance for domestic foods and cosmetics through compliance programs that guide surveillance and enforcement activities.
The greatest challenge the Foods Program faces is how to cope with the growth of the regulated industry and the growth and changes in health risks at a time when resources are decreasing. To improve the coverage for the entire food supply, FDA will:
- Target products with the highest risk of violating food safety and sanitation
standards
- Increase the number of domestic establishment inspections,
- Significantly reduce the interval between inspections in domestic food establishments,
with an emphasis on dietary supplement establishments and expand import coverage
for foods
- Leverage its resources by working with USDA, CDC, other federal agencies
and states to establish an integrated food safety system for the nation, including
outbreak response coordination and investigation; information sharing and
data collection; minimum uniform standards; and laboratory operation and coordination
- Increase the coverage of imports and ensure the existence of an effective
international food safety net through three substrategies:
- Applying preventive measures at the source of production and thereby
reducing the probability that products that violate United States standards
will be exported to the United States.
- Making rapid and reliable decisions at the border about whether products
should be allowed to enter the United States by conducting additional
foreign inspections/evaluations and expanding the reviews of electronic
filers.
- Targeting products that violate United States standards at the border
and preventing their entry, especially those products with a higher risk
for violations and those products by firms with historical violations.
The first import substrategy merits further explanation. It is accomplished
through several substrategies. First, FDA negotiates bilateral and multinational
agreements on specified products and in forums that result in development
of acceptable international product standards (for example, the United Nations
Food and Agricultural Organization's Codex Alimentarius). These standards
can be extended to a large percentage of imports through agreements in which
source countries confirm product conformance to these standards. Second,
FDA provides educational and technical assistance to foreign governments.
Third, the agency evaluates food safety systems in foreign nations. Finally,
FDA enters into international agreements that permit the Agency to establish
safety and sanitation standards that food products must meet before they
are exported to the United States.
Adverse Event Reporting
Once food and cosmetic products are commercially available to consumers, it is also important to monitor and evaluate adverse events associated with the consumer use of these products. The development of more effective surveillance techniques for detecting, preventing, and controlling potential hazards associated with food and cosmetic products is a top priority for the Agency. The Agency needs better ways of identifying problems with dietary supplements. In view of the rapidly increasing use of, and safety hazards associated with some dietary supplements (e.g., Ephedra) and other special nutritional products, improving databases/ surveillance systems for these food products is also a top priority for FDA.
With resources received in FY 2001, FDA will continue to work diligently to enhance the Agency's capacity for collecting, monitoring and evaluating adverse events by:
- Improving the infrastructure with hardware/ software upgrades
- Increasing epidemiological staff
- Creating a series of links with existing database and surveillance systems
external to the Agency
B. Summary of Performance Goals
Performance Goals |
Targets |
Actual Performance |
Reference |
6.
Achieve adoption of the Food
Code by at least one state agency
in 33 states in the USA. (11010)
|
FY 03: 33
FY 02: 28
FY 01: 25
FY 00: 18
FY 99: 13 |
FY 03:
FY 02:
FY 01: 28
FY 00: 20
FY 99: 15 |
|
7.
Inspect 95 percent of high-risk
domestic food establishments
once every year. (11020)
|
FY 03: at least 95 percent once
every year
FY 02: at least 95 percent once
every year
FY 01: at least 90 percent once
every year
FY 00: 90 100 percent Once
every one to two years
FY 99: NA |
FY 03:
FY 02:
FY 01: 74 percent
FY 00: 91 percent
FY 99: NA |
|
8.
Assure that FDA inspections of
domestic food establishments
result in a high rate of conformance
(at least 90 percent) with FDA
requirements. (11011)
|
FY 03: NA
FY 02: NA
FY 01: at least 90 percent
FY 00: 90-100 percent
FY 99: 90-100 percent |
FY 03:
FY 02:
FY 01: 99 percent
FY 00: 97 percent
FY 99: 98 percent |
|
9.
Increase the number of import
exams of food products. (11021.02)
|
FY 03: N/A
FY 02: N/A
FY 01: 60,000
FY 00: 60,600
FY 99: N/A |
FY 03:
FY 02:
FY 01: 29,751
FY 00: 28,275
FY 99: 32,000 |
|
10.
Increase the number of audits
and assessments of foreign food
safety systems, with an emphasis
on high volume exporters to the
U.S. (11028)
|
FY 03: N/A
FY 02: N/A
FY 01: 10
FY 00: N/A
FY 99: N/A |
FY 03:
FY 02:
FY 01: 0
FY 00: N/A
FY 99: 4 |
|
11.
Increase the number of physical
exams by 100% to 48,000 exams
and conduct sample analyses on
products with suspect histories.
(11036)
|
FY 03: 100% (48,000 exams)
FY 02: Increase food import surveillance
by hiring 300 new investigators
and analysts who will increase
the number of physical exams
by 97% to 24,000 exams and conduct
sample analyses on products with
suspect histories.
FY 01: NA |
FY 03:
FY 02:
FY 01: 12,169
|
|
12.
Enhance productivity at the 45
additional ports through focused
training.
(11037) |
FY 03: Enhance productivity at
the 45 additional ports through
focused training.
FY 02: Extend import coverage
to an additional 45 ports that
handle significant quantities
of FDA-regulated products.
FY 01: NA
FY 00: NA
FY 99: NA |
FY 03:
FY 02:
FY 01: NA
FY 00: NA
FY 99: NA |
|
13.
Maintain current level of monitoring
for pesticides and environmental
contaminants in foods through
the collection and analysis of
a targeted cohort of 8,000 samples.
(11027)
|
FY 03: 8,000 +
FY 02: 8,000 +
FY 01: 8,000 +
FY 00: N/A
FY 1999: N/A |
FY 03:
FY 02:
FY 01: 7,300 total (2,475 domestic
and 4,900 imported)
FY 00: 7,400 total (2,500 domestic and 4,900 imported)
FY 99: 9,400 total pesticide and chemical contaminant samples: 3,400 domestic
and 6,000 imports. |
|
TOTAL FUNDING:
($000) |
FY 03: 354,404
FY 02: 347,954
FY 01: 247,699
FY 00: 240,044
FY 99: 209,972 |
|
|
C. Goal-by-Goal Presentation of Performance
6. Achieve adoption of the
Food Code by at least one state agency
in 33 states in the USA. (11010).
- Context of Goal:
The Food Code is a reference document
for regulatory agencies responsible
for overseeing food safety in retail
outlets, such as restaurants and
grocery stores, and institutions,
such as nursing homes and child
care centers. It is neither federal
law nor federal regulation, but
may be adopted voluntarily and
used by agencies at all levels
of government that have responsibility
for managing food safety risks
at retail.
To achieve the public health goal
of reducing foodborne illness to
the fullest extent possible, steps
must be taken at each point in
the farm-to-table chain where hazards
can occur. Adoption by all jurisdictions
of the Food Code would result in
uniform national standards and
provide the foundation for a more
uniform, efficient, and effective,
national food safety system. FDA
endorses the Food Code because
the Code provides public health
and regulatory agencies with practical
science-based advice and manageable,
enforceable provisions for mitigating
risk factors known to contribute
to foodborne disease.
In June 1998, the Secretary of
Health and Human Services, Donna
Shalala, and the Secretary of Agriculture,
Dan Glickman, wrote to U.S. Governors
asking them to support adoption
of the Food Code by agencies in
their states that have responsibility
for regulating retail establishments
that sell or serve food should
use the Food Code as a model to
help develop or update their own
food safety rules and provide consistency
among jurisdictions.
- Data Sources: Field Data Systems
- Performance: The Food Code was revised and a notice of
its availability was published in the Federal Register on February 22, 1999
(64 FR 8576). In FY 1999, agencies in 15 States adopted the Food Code. State
agencies achieving adoption of the Food Code were: Minnesota, Rhode Island,
New Hampshire, Missouri, North Dakota, South Dakota, Nebraska, Mississippi,
Texas, Florida, Kansas, Florida, Utah, Arizona and Iowa. In FY 2000, agencies
in 20 states have adopted the Food Code. In FY 2001, at least one state agency
in 28 states adopted the Food Code.
7. Inspect 95 percent of high-risk domestic food establishments once
every year. (11020)
- Context of Goal: The Agency has defined high-risk establishments
as those producing foods with the greatest risk for microbial contamination
and those foods requiring specific components for a safe and nutritious product.
Foods following under this definition were infant formula, medical foods,
scrombotoxic seafood, molluscan shellfish, low acid canned and acidified foods,
ready to eat foods such as processed fresh fruits and vegetables, bakery goods
(with filling), soft and soft ripened cheeses, cooked pasta dishes, prepared
salads and heat and serve products. Based on this definition, the Agency estimates
that there are approximately 7,000 such establishments in its establishment
inventory. In FY 2001, the number of high-risk establishment inspections conducted
annually will be increased to include coverage of the entire inventory. FDA,
in conjunction with the States, will focus on those establishments that produce
foods most susceptible to contamination of foodborne pathogens. The percentage
range provided for the inspection frequency allows for unanticipated redirection
of resources for emergencies or related incidents, such as foodborne illness
outbreaks. In FY 2002, the entire high-risk establishment inventory is expected
to increase and thus the target for FY 2002 has been changed from 90 -100
percent to at least 95 percent, to anticipate the level of increase in the
number of high-risk establishment inspections.
- Data Sources: Field Data Systems
- Performance: In FY 2000, the number of high-risk food inspections
was approximately 5700, of the identified possible inventory of high-risk
product/process domestic firms. In FY 2001, the Agency accomplished only 74
percent of the identified possible inventory of high-risk product/process
domestic firms. The reason FDA missed this goal was because the Agency purposefully
diverted resources for these inspections to focus on an even greater threat
of BSE that was breaking out in Europe at the time.
8. Assure that FDA inspections of domestic food establishments (including
domestic seafood establishments), in conjunction with the timely correction
of serious deficiencies identified in these inspections, result in a high rate
of conformance (at least 90 percent) with FDA requirements. (11011)
- Context of Goal:
(Goal Dropped for FY 2002 and 2003)
In previous FDA performance plans,
goals were established for maintaining
the level of industry conformance
to FDA requirements at 90 percent
or above for each of the Agency
product-oriented programs. This
year we are recommending that these
goals be deleted from the Plan.
This is our rationale: Inspections
are the Agency's method for determining
whether an establishment is in
or out of compliance with FDA requirements.
Because of resource constraints,
the Agency must allocate a significant
proportion of its inspections to
high risk situations, such as food
firms who are producing high risk
foods, or to emergency situations
such as BSE. The number of remaining
inspections each year is not adequate
to draw a statistically valid inference
about the compliance status of
an entire industry at a reasonably
high level of confidence.
It is the Agency's professional
judgement that the majority of
firms in the regulated industries
are in conformance with FDA's requirements.
Based on the Agency's experience
over several years, that percentage
in general, has remained at 90
percent or above. Thus, establishing
a performance goal that simply
describes the stable state of the
industry does not provide useful
new information; nor does it serve
as a management tool to drive the
overall industry to a higher level
of conformance.
- Data Sources: Field Data Systems
- Performance: In FY 1997, 1998 and 1999, FDA inspections
of domestic food establishments (excluding the domestic seafood industry)
resulted in a 98 percent rate of conformance with FDA requirements. FDA inspections
of domestic food establishments, in conjunction with the timely correction
of serious deficiencies identified in these inspections, resulted in a 97
percent rate of conformance in FY 2000. In FY 2001, actual conformance was
99 percent.
9. Increase the number of import exams of food products. (11021.02)
- Context of Goal: (Goal Dropped for FY 2002 and 2003).
This goal has been dropped because it is too coarse a measure of the effort
FDA is expending to reduce the threat from imports. The planned 60,600 "import
exams" is actually a catch all category that includes counts of several different
kinds of activity at the border, including: physical exams, sample analyses,
examination of paper manifests and product detentions. FDA has determined
that the most important measure for import safety is the number of physical
exams, and our new import coverage goal focuses on those (Goal 11).
- Data Sources: Field Data Systems
- Performance:
The actual performance figures
reported in the table for FY 1999,
2000 and 2001, are the combined
totals of only the number
of physical exams and laboratory
samples analyzed, not the combination
of additional activities initially
envisioned. In FY 2001, 29,751
import exams were conducted. This
includes 17,582 sample analyses
in addition to the 12,169 physical
exams mentioned in the new import
exam performance goal (Goal 11).
Our new Goal 11 focuses on physical
exams exclusively. It is a more
sensitive measure of the effort
dedicated to reducing risk at the
border, and it is a performance
area where rapid improvements can
be shown as a result of budget
increases received in FY 2002 and
2003.
10. Increase the number of audits and assessments of foreign food safety
systems, with an emphasis on high volume exporters to the U.S. to ensure a level
of food safety protection comparable to domestically produced foods. (11028)
- Context of Goal:
(Goal Dropped for FY 2002 and 2003).
Traditionally, FDA has been viewed
as a domestic public health agency,
charged primarily with protecting
the health and economic interests
of American consumers. This traditional,
domestically oriented regulatory
approach, complemented by selective
enforcement programs for imports,
was quite effective until the emergence
over the last twenty years of the
"global marketplace", where foods
available to U.S. consumers may
originate in any of more than one
hundred countries. Imported foods
now constitute more than 10 percent
of the U.S. food supply, and for
some commodities, such as many
fresh fruits and vegetables, 40
percent or more are imported. The
volume of imports is increasing
at a rate that far exceeds the
level of resources that FDA can
devote to inspections, even with
recent resource increases received
under the Food Safety Initiative.
FDA data show that the number of
imported food entries has doubled
over the past 7 years and that,
based on recent trends, imports
are expected to increase by an
additional 30 percent by FY 2002.
FDA is using three main strategies
to target its efforts and to better
utilize existing resources earmarked
for ensuring the safety of imported
foods. These strategies include
reducing the probability that violative
products will be exported to the
United States; making rapid and
reliable decisions on product entry
at the U.S. borders; and targeting
violative products at the border
and preventing their entry.
This goal supports the first strategy
of reducing the probability that
violative products will be exported
to the U.S. FDA conducts a thorough
assessment of foreign food safety
systems to maintain an assurance
that a country's exports comply
with the standards established
by the FD&C Act. The assessment
of foreign food safety systems
includes food production, storage,
transportation and delivery. This
is important for determining the
equivalence of foreign country
standards, for assuring that foreign
nations have the regulatory sitemaps
in place to meet those standards
and for developing international
mutual recognition agreements.
In addition, the results of these
assessments are useful in determining
training, education, and infrastructure
development needs. Foreign countries
must request an audit or assessment
of their food safety system from
FDA. FDA prompts these requests
by contacting foreign officials.
The Agency is concentrating on
nations with a high volume of exports
to the U.S., particularly seafood
and produce exporters. Once a food
safety system is audited, the Agency
plans to re-evaluate the system
annually. In FY 1998, FDA completed
food safety system assessments
in two countries: Honduras and
Trinidad & Tobago. In FY 1999,
FDA conducted audits/assessments
of foreign food safety systems
in four countries: Costa Rica,
Nicaragua, Guatemala and El Salvador.
- Data Sources: Field Data Systems
- Performance: This was a new commitment in FY 2001. The
Agency did not complete any audits and assessments of foreign food safety
systems due to a redirection of resources to other international issues.
11. Increase the number of physical exams by 100 % to 48,000 exams
and conduct sample analyses on products with suspect histories. (11036)
- Context of Goal: Traditionally, FDA has been viewed as
a domestic public health agency, charged primarily with protecting the health
and economic interests of American consumers. This traditional, domestically
oriented regulatory approach, complemented by selective enforcement programs
for imports, was quite effective until the emergence over the last twenty
years of the "global marketplace", where foods available to U.S. consumers
may originate in any of more than one hundred countries. Imported foods now
constitute more than 10 percent of the U.S. food supply, and for some commodities,
such as many fresh fruits and vegetables, 40 percent or more are imported.
The volume of imports is increasing at a rate that far exceeds the level of
resources that FDA can devote to inspections, even with recent resource increases
received under the Food Safety Initiative. FDA data show that the number of
imported food entries has doubled over the past 7 years. Currently, FDA receives
five million line imports and therefore surveillance needs to be increased.
In FY 2002, 400 additional people will be hired to carry out border activities.
Of these 400, 300 will be directly used to conduct physical examinations and
follow up leads on suspicious products. The remaining 100 people will be used
to conduct laboratory analyses. Additional duties will include:
- pursuing compliance case work, including carrying out criminal investigations;
- ensuring the quality of filer reviews of import entries;
- expediting the triage process through use of the OASIS system; and
- acting as liaisons between firms and FDA to explain the purpose of sample
collection, the time frame for collecting and notifying firms of the results
in a timely manner. This function is critical to importers and brokers
who must have timely information to determine appropriate business decisions.
A 100% increase in physical exams over planned FY 2002 figures is estimated.
This percentage increase is based on the productivity expected from 300
additional investigators. The productivity increase of 100% is based on
a number of calculations, including: timing of recruitment, training time
required, workload modules for physical exams and time allowed for follow-up
investigation of suspicious products. Also factored into the productivity
increase is the estimated import workload increase of 10% a year. Because
of the increased emphasis on the potential for terrorist threats, the
workload module for physical exams, and the time required to follow up
on suspicious products has been increased. It should be noted that even
with more rapid recruitment through the Agency's 'quick hire' program,
and focused training of new recruits [both accomplished through web-based
improvements], the field investigator requires time to reach full productivity.
The ramp-up is 10% productivity at the end of the training period, 50%
productivity one year after training and 100% productivity after two years.
In addition, the time of seasoned investigators must be partially diverted
to provide hands-on training to new investigators that will be coming
on board in large numbers over the next two years. Significant increases
in productivity should be realized after new investigators have been on
board for a year.
- Data Sources: Field Data Systems
- Performance: This goal is new for FY 2002 and FY 2003,
so there was no FY 2001 performance target, but the FY 2001 baseline was 12,169
physical exams. It should be noted that the measure being used for this performance
goal - 'physical exams' - is different than the measure used in Goal # 9 which
is now being dropped. Goal #9 used the measure 'import examinations,' which
was a catch all category that includes counts of several different kinds of
activity at the border. That is why the total number of 'import examinations'
envisioned in Goal 9 is much higher than the number of physical exams alone.
The baselines are not comparable. FDA believes that the measurement of physical
exams - which is 'hands-on' examination of the product - is a more relevant
measure of the Agency's attempt to address potentially high risk products
at the border.
12. Enhance productivity at the 45 additional ports through focused
training. (11037)
- Context of Goal: The President's Budget annualized the
FY 2002 Budget Supplemental for Counter Terrorism, which will enable FDA to
enhance inspection and analytical coverage of imported products. This will
have the effect of more than doubling the Field import staff and substantially
increasing the number of physical exams and lab analyses conducted at the
border. In FY 2002, FDA will be able to extend import coverage to an additional
45 ports that handle significant quantities of FDA regulated products. In
FY 2003, focused training should increase productivity of the new investigators
at these ports.
- Data Sources:
- Performance: This is a new goal for FY 2002 and FY 2003.
13. Maintain current level of monitoring for pesticides and environmental
contaminants in foods through the collection and analysis of a targeted cohort
of 8,000 samples. (11027)
- Context of Goal:
Three federal government agencies
share responsibility for the regulation
of pesticides. The Environmental
Protection Agency (EPA) registers
and approves the use of pesticides
and sets tolerances (the maximum
amount of residue that is permitted
in or on a food) if use of that
particular pesticide may result
in residues in or on food. The
USDA's Food Safety and Inspection
Service (FSIS) is responsible for
enforcing tolerances in meat, poultry,
and certain egg products. FDA is
charged with enforcing tolerances
in imported foods and in domestically
produced foods shipped in interstate
commerce. FDA also acquires data
on particular commodity/pesticide
combinations and carries out its
market basket survey, called the
Total Diet Study. In conducting
the Total Diet Study, FDA personnel
purchase foods from supermarkets
or grocery stores four times a
year, once from each of four geographic
regions of the country. The foods
are prepared table-ready and then
analyzed for pesticide residues
and environmental contaminants.
The levels of pesticides found
will be used in conjunction with
USDA food consumption data to estimate
the dietary intake of the pesticide
residues.
Under the regulatory monitoring
program, FDA samples individual
lots of domestically produced and
imported foods and analyzes them
for pesticide residues to enforce
the tolerances set by EPA. Domestic
samples are collected as close
as possible to the point of production
in the distribution system; Import
samples are collected at the point
of entry into U.S. commerce. FDA's
pesticide program focuses its efforts
on raw agricultural products which
are analyzed as the unwashed, whole
(unpeeled), raw commodity. Processed
foods are also included. If illegal
residues (those that are above
EPA tolerances) are found in domestic
samples, FDA can invoke various
sanctions, such as a seizure or
injunction. For imports, shipments
may be stopped at the port of entry
when illegal residues are found.
"Detention without physical examination"
may be invoked for imports based
on the finding of one violative
shipment if there is reason to
believe that the same situation
will exist in future lots during
the same shipping season for a
specific shipper, grower, geographic
areas, or country.
Personnel in FDA Field offices
interact with their counterparts
in many states to increase FDA's
effectiveness in pesticide residue
monitoring. In many cases, Memoranda
of Understanding or more formal
Partnership Agreements have been
established between FDA and various
state agencies. These agreements
provide for more efficient monitoring
by broadening coverage and eliminating
duplication of effort, thereby
maximizing Federal and state resources
allocated for pesticide activities.
In planning the types and numbers
of samples to collect, FDA considers
several factors. These factors
include: recently generated state
and FDA residue data, regional
intelligence on pesticide use,
dietary importance of the food,
information on the amount of domestic
food that enters interstate commerce
and of imported food, chemical
characteristics and toxicity of
the pesticide, and production volume/pesticide
usage patterns. In FY 2001, FDA
expects to analyze 8,000 plus.
In FY 2002, FDA expects to analyze
8,000 plus samples for pesticide
residues and 1,750 samples for
dioxin. FDA must maintain resource
levels devoted to the sampling
and analyses of pesticide and environmental
contaminants, specifically dioxin,
not only to ensure that the U.S.
food supply is safe, but also to
reduce dietary exposure.
- Data Sources: FACTS, CFSAN website
- Performance: FY 1998 - 8,500 samples (3,600 domestic and
4,900 imports); FY 1999 - 9,400 samples (3,400 domestic and 6,000 imports);
FY 2000 - 7,400 samples (2,500 domestic and 4,900 imports). FY 2001 - 7375
samples (2,475 domestic and 4,900 imports.)
2.2.3 Verification and Validation
Public health data systems currently are not adequate to provide accurate and comprehensive baseline data needed to draw direct relationships between FDA's regulatory activities and changes in the number and types of foodborne illnesses that occur annually in this country. Because of the need to have better data on food related illnesses, FDA and USDA began working with CDC in 1995 to improve food safety surveillance. FoodNet, an active surveillance program, was created through this joint effort. Currently there are nine FoodNet sites.
These sites, which operate in areas that are representative of the geographic and demographic population distributions in this country, provide much better data on the number of foodborne illnesses and trends in terms of the types of contaminants that are causing these illnesses. This type of information can be critical to efforts by food safety agencies to redirect their regulatory and research resources to those food safety problems that pose the greatest threat to the health of consumers. Moreover, in 2002 when the data will be sufficient in volume and quality to establish baselines against which to measure changes in foodborne illnesses, FDA will be in a better position to establish broad scope outcome goals that are essential to effective performance planning.
Food Safety regulation development and research activities are planned and tracked through internal management systems. Progress on the development of regulations is tracked mainly through CFSAN's document tracking system and the Federal Register document tracking system. These systems permit the Agency to track the processing of regulations from the time they are filed to the point at which action is complete-usually the publication of a final regulation in the Federal Register.
CFSAN uses a number of internal data systems to track premarket review progress. These include the Management Assignment Tracking System (MATS) to track progress of petition reviews, Correspondence Tracking System (CTS) to track progress on biotechnology consultations, reviews of GRAS notifications, nutrient content claims, and health claims petitions/notifications. Outcome-oriented performance information can be extracted from MATS only by a labor-intensive manual process. CFSAN's internal data systems are limited to tracking time to a completed review and do not have the capability to track distinct phases of the review process. In FY 1998, the Office of Premarket Approval's (OPA) internal database was modified to permit more detailed tracking of CFSAN's action on biotechnology consultations. In FY 1999, CFSAN implemented an electronic workflow system that will replace MATS and CTS and permit real-time monitoring of review progress. The electronic workflow system is expected to be in full use in FY 2001. The new system will track automatically actions related to the processing of food and color additive petitions, GRAS petitions and biotechnology consultations.
FDA uses a variety of data systems to develop and verify performance goals for its food safety activities. Among these are several field data systems. The most important of the field data systems are the Program Oriented Data System (PODS) and the Operational Administrative System for Imports (OASIS). PODS tracks field activities conducted by FDA's field force and the firms over which FDA has legal responsibility. Information provided by this system includes data on the number of inspections, wharf examinations, sample collections and analyses as well as the time spent on each. OASIS, which is coordinated with the U.S. Customs Service, provides data on what products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. In FY 2001, the Field Accomplishments Tracking System (FACTS) will be the primary mechanism for tracking compliance activities for the domestic food industry. The National Seafood HACCP Compliance Database System maintains information on seafood HACCP inspections conducted by FDA and states in partnership with FDA. Standardized forms (Cardiff forms) assure comparability of HACCP compliance data whether FDA or states conduct the inspections. Another field data collection instrument is the field survey. Field surveys are special assignments that are developed and implemented specifically to collect information needed to more thoroughly evaluate the nature and extent of particular postmarket food safety problems.
Data are also gathered through a number of other surveys designed for specific purposes. These include the Health and Diet Survey that provides information required to evaluate the impact of the Agency's food labeling activities. These surveys include questions that are designed to query consumers on how they use food labeling information to make decisions to use or purchase food products. Another survey is the NASS survey currently being developed jointly by FDA and USDA to evaluate the impact of GAPs and GMPs for improving the safety of fresh fruits and vegetables. The survey questions will be designed to provide data on practices employed in the production and processing of fresh fruits and vegetables. The results of the NASS surveys will be used to establish baselines for industry practices as well as evaluate the impact of voluntary GAPs and GMPs on improving production and processing practices for fresh produce.
Comprehensive data on illness caused by food and cosmetic products is critical to efforts to protect the health of consumers. Some of the illness data are provided by databases that contain information on adverse events, reported by consumers and industry on food and cosmetic products. In FY 2001, the Agency began improving the quality and accessibility of data on adverse events through the development and implementation of a new adverse event reporting system for dietary supplements. In FY 2002, the Agency will build upon the system nodule for dietary supplements by developing and implementing an integrated adverse reporting system for all food and cosmetic products.
Proposed research projects are subjected to management reviews prior to implementation and periodic management reviews after the projects have been initiated. The primary planning and management system for food safety research is the Center Program Resources (CPR) plan system that provides quarterly resource use reports and semi-annual reports on accomplishments versus planned milestones. In FY 2000, the Center formed a research management task group responsible for evaluating related processes and systems and developing recommendations for improvement. In addition, research projects are subjected to periodic external peer reviews. Peer reviews by recognized scientific experts in various disciplines related to food safety provide objective feedback that helps FDA evaluate the progress, quality and relevance of its research activities. In addition, risk assessment models are verified periodically using statistical models that assess their ability to make rapid and accurate estimates of risks associated with a particular food safety hazard.
In FY 1999, the Center began implementation of its Resource Planning, Prioritization,
and Allocation Process. The primary purpose of this Process is to provide pertinent
data throughout the fiscal year on program activities, including GPRA performance
goals, Center program priorities, Congressional directives, statutory responsibilities
under FDAMA, and Food Safety Initiative objectives.
Contact Information:
Planning Staff, Office of Planning, FDA
Phone: 301-827-5210
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