Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005
FOODS
|
|
FY 2003
Actual |
FY 2004
Enacted1/2/ |
FY 2005
Estimate |
Increase or
Decrease |
Program Level |
$406,824,000 |
$410,674,000 |
$470,405,000 |
+$59,731,000 |
Center |
$147,304,000 |
$144,715,000 |
$164,235,000 |
|
FTE |
950 |
901 |
903 |
+2 |
Field |
$259,520,000 |
$265,959,000 |
$306,170,000 |
+$40,211,00 |
FTE |
2,217 |
2,086 |
2,129 |
+43 |
Budget Authority |
$406,824,000 |
$410,674,000 |
$470,405,000 |
+$59,731,000 |
Cost of Living-Pay 3/ |
|
|
$5,755,000 |
+$5,755,000 |
Food Defense - Counterterrorism4/ |
|
$110,777,000 |
$171,527,000 |
+60,750,00 |
FTE |
|
|
|
+103 |
Administrative Efficiencies |
|
|
-$6,774,000 |
-$6,774,000 |
FTE |
|
|
-58 |
-58 |
Budget Authority FTE |
3,167 |
2,987 |
3,032 |
+45 |
1/ Includes a Budget Authority rescission
of 0.59 percent for a total of $2,438,000 for the Foods program.
2/ In FY 2004, a total of 104 Human Resources
FTE was transferred from the FDA to the Department as part of the
Secretary's One HHS Initiative.The Foods Program's share of this transfer
was 28 FTE.
3/ Pay increases shown on separate line, and
not reflected in individual initiative areas.
4/ Foods program portion of $65,000,000 Food
Defense Counter terrorism funds. Additional increase of $1,250,000
is in NCTR and $3,000,000 in Other Activities (Crisis Management).
|
|
Historical Funding and FTE Levels
Fiscal Year |
Program Level |
Budget Authority |
User Fees |
Program Level FTE |
2001 Actuals |
$287,504,000 |
$287,504,000 |
0 |
2,445 |
2002 Actuals 5/1 |
$393,256,000 |
$393,256,000 |
0 |
2,734 |
2003 Actuals |
$406,824,000 |
$406,824,000 |
0 |
3,167 |
2004 Enacted |
$410,674,000 |
$410,674,000 |
0 |
2,987 |
2005 Estimate |
$470,405,000 |
$470,405,000 |
0 |
3,032 |
5 1/Includes FDA's FY 2002 Appropriation and
the Counter terrorism Supplemental.
MISSION
- Ensure that the food supply, quality of foods, food ingredients, and dietary
supplements are safe, nutritious, wholesome, and honestly labeled and that
cosmetics are safe and properly labeled;
- Set standards and develop regulations for the food industry;
- Take timely and appropriate action on new food ingredients and dietary supplements
before they go on the market to ensure their safety and effectiveness;
- Research ways to provide the necessary basis for regulatory decisions;
- Identify food-related health hazards;
- Take corrective action to reduce human exposure to food related health hazards
and the possibility of food-related illnesses and injuries;
- Safeguard the American public by defending the food system against terrorist
attacks, major disasters, and other emergencies; and,
- Educate and train consumers and industry on food safety and food security.
Scope of Responsibility
The Foods Program promotes and protects the public's health by ensuring
that the food supply is safe, sanitary, wholesome, and honestly labeled,
and that cosmetic products are safe and properly labeled for the American
public. Consumers spend over twenty cents out of every consumer dollar
on FDA regulated products, and 75 percent % is spent on foods. The Foods
program regulates $240 billion worth of domestic food, $15 billion worth
of imported foods, and $15 billion worth of cosmetics sold across state
lines. This regulation takes place from the products' point of U.S. entry
or processing to their point of sale, with approximately 50,000 food establishments
(includes more than 30,000 U.S. food manufacturers and processors and
over 20,000 food warehouses) and 3,500 cosmetic firms. These figures do
not include the roughly 600,000 restaurants and institutional food service
establishments and the 235,000 supermarkets, grocery stores, and other
food outlets regulated by state and local authorities that receive food
safety guidance, model codes, and other technical assistance from FDA.
The U.S.food supply is among the worlds safest,and FDA will continue to
ensure consumer confidence in the food we eat. |
BACKGROUND
The Foods Program regulates all food except meat, poultry, and frozen and dried
eggs,which, are regulated by the U.S. Department of Agriculture. The Center
for Food Safety and Applied Nutrition (CFSAN), in conjunction with the Agency's
field staff (ORA), are responsible for promoting and protecting the public's
health by ensuring that the nation's food supply is safe, sanitary, wholesome,
and honestly labeled, and that cosmetic products are safe and properly labeled
for the American public.The terrorist attacks of September 11th have also added
a food security/defense dimension to the FDA's current food safety efforts.
Additionally, as we enter the 21st Century,current trends in the food industry
promise better nutrition, greater economies and wider choices for the U.S. consumer
than ever before. To illustrate:
- 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 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; and,
- The dietary supplements industry has grown dramatically, as has consumption
of dietary supplements.
Each of these developments presents food safety regulatory and food security/defense
challenges for FDA. The Agency's job is to give consumers the confidence to
enjoy the benefits of these expanded food choices.
CFSAN's primary responsibilities include:the safety of substances added
to food, e.g., food additives (including ionizing radiation) and color additives;
the safety of foods and ingredients developed through biotechnology;seafood
Hazard Analysis and Critical Control Point (HACCP) regulations;regulatory and
research programs to address health risks associated with food borne chemical,
and biological contaminants;regulations and activities dealing with the proper
labeling of foods (e.g., ingredients, nutrition health claims) and cosmetics;regulations
and policy governing the safety of dietary supplements, infant formulas, and
medical foods;safe and properly labeled cosmetic ingredients and products; food
industry postmarket surveillance and compliance; consumer education and industry
outreach; cooperative programs with state and local governments; and, international
food standard and safety harmonization efforts.The terrorist attacks of September
11th has increased CFSAN's role in the nation's counter terrorism
efforts, as in 2003 and beyond the Center has the responsibility for development
and implementation of food security concerns in the Public Health Security and
Bio terrorism Preparedness and Response Act of 2002 (the Bio terrorism Act)
. Although our food supply is among the world's safest, the increase in variety
of foods and the convenience items available has brought with it public health
concerns. Because a growing proportion of the American food supply is imported,
CFSAN also works with international organizations (World Health Organization,
Codex Alimentarius Commission--an international food standard-setting organization
of the Food and Agriculture Organization) and occasionally directly with foreign
governments to ensure their understanding of U.S. requirements and to harmonize
international food standards.
In support of the Foods program, ORA conducts risk-based domestic and foreign
postmarket inspections of food manufacturers to assess their compliance with
Good Manufacturing Practice (GMP). ORA inspects thousands of domestic firms
that have been identified as high-risk food establishments consisting of manufacturers,
packers/repackers, and warehouses processing products. These include: modified
atmosphere packaged products acidified and low acid canned foods, seafood, custard
filled bakery products, soft, semi-soft, soft-ripened cheese and cheese products,
un-pasteurized juices, sprouts or processed leafy vegetables, fresh vegetables
shredded for salads and processed root and tuber vegetables, sandwiches, prepared
salads, infant formula, and medical foods. In addition to overseeing regulated
products on a surveillance or "for cause" basis when a problem is
encountered, ORA staff responds to emergencies and investigates incidents of
product tampering and terrorist events or natural disasters that may impact
FDA regulated goods. To complement the regular field force, the Office of Criminal
Investigations (OCI) investigates instances of criminal activity in FDA-regulated
industries.
Foods Program Increases for FY 2005
(By FDA Strategic Goal)
FDA Strategic Goal |
FY 2005 Increase |
What the Increase Buys |
Related Performance Goal(s) |
Strong FDA |
Cost of Living-Pay +$5,755,000 |
- Ensures that the Foods Program is able to continue to support its
highly specialized staff.
|
- Complete review and action on the safety evaluation of food and color
additive petitions with 360 days of receipt;
- Respond to 95% of notifications for dietary supplements containing
"new dietary ingredients" within 75 days; and,
- Review 95% of premarket notifications for food contact substances
within the statutory time limit of 120 days.
|
Counter terrorism Protecting America from Terrorism |
Food Defense -CTT--+(+ $60,750,000) |
- 15 new State Labs added to Food Emergency Response Network (FERN).
Laboratory equipment, supplies, training and security to enhance State
capability to assist in FDA's Food Defense activities;
- A secure food laboratory IT network (eLEXNET) for the real time sharing
of information on a national basis;.
- Increased domestic and import inspections of FDA regulated foods;
- Increased research on prevention technologies, agent characteristics,
new methods, and dose response relationships; and,
- Improved coordination and integration of existing food surveillance
capabilities with the Department of Homeland Security's integration
and analysis function, as part of the government-wide Bio-Surveillance
Initiative.
|
- Increase national laboratory capacity to test food samples in the
event of a terrorist attack;.
- Expand federal/state/local involvement in FDA's eLEXNET system by
having 104 laboratories participate in the system by the end of FY 2005;.
- Increase Inspectional Coverage of Domestic Firms and Imported Goods
to reduce the risk of contaminated product entering domestic commerce;.
- Develop effective protection strategies to "shield" the food supply
from terrorist threats; and,
- Improve early attack warning and bio-surveillance capabilities at
the national level to prepare against a potential terrorist attack.
|
PROGRAM RESOURCES CHANGES
Budget Authority
Cost of Living- Pay: +$5,755,000
FDA's request for pay cost increases is essential to accomplishing its mission.
Without a specially trained national cadre of scientific staff, FDA's ability
to adequately carry out the mission of protecting public health and providing
consumer safety will be compromised. FDA must maintain staffing levels and scientific
capabilities that meet the demands of an increasing workload and new challenges.
Payroll costs, which account for over 60 percent of our total budget, significantly
impact all FDA activities.
The total Agency request for pay increases is $14,352,000. The foods portion
of this increase is $5,755,000. Without this, the FDA's ability to fulfill its
mission to protect the public health by helping safe and effective products
reach the market in a timely way, and monitoring products for continued safety
after they are in use will be significantly reduced.
Food Defense - Counter terrorism: + $60,750,000 and +103 FTE (includes+$5,000,000
for biosurveillance)
FDA must uphold its responsibility for ensuring the safety of approximately
80 percent of the nation's food supply. The possibility of food products being
used as a vehicle for attack is particularly worrisome because such an event
potentially affects everyone in the U.S. FDA must have the capability to assess
and then reduce risks associated with unexpected and potentially widespread
health and safety threats. Resources would allow the FDA to invest in the protection
of citizens by supporting the following priorities and objectives:
- Increasing Analytic Surge Capacity in the Event of Terrorist Attack on Food;
FDA will develop a nation-wide laboratory testing capacity for biological,
chemical and radiological threat agents;
- Developing effective protection strategies to "shield" the food supply from
terrorist threats;
- Increasing inspectional coverage of domestic firms and imported goods to
reduce the risk of contaminated product entering domestic commerce;
- Improving early attack warning and bio-surveillance capabilities at the
national level to prepare against a potential terrorist attack; and,
- Providing capacity for a rapid, coordinated response to a threat(s) or attack(s)
on the food supply.
Specific activities include:
Food Emergency Response Network (FERN) and eLEXNET
- Enhancing the capabilities of state food testing so they are capable of
handling pathogens associated with Bio terrorism at a BL-2 level or higher;
- Equipping additional state food chemistry labs with the instrumentation
needed to rapidly screen foods for the array of toxic chemical of concern;
- Integrating the Food Emergency Response Network (FERN) with the nations'
food testing laboratories and complimenting CDC's Laboratory Response Network
(LRN) to detect routine threat agents in food. FERN will strengthen both federal
and state food testing capabilities and would be called upon to respond to
a terrorist attack or national emergency involving the food supply;
- Providing equipment, supplies, and training to promote security and to enhance
state capability to assist in FDA's Food Security activities;
- Providing for laboratory testing to validate new methods and to provide
for technology transfer and proficiency testing programs to standardize intra-
and inter-agency laboratory performance;
- Providing a total of $28,000,000 ($23,000,000 in new budget authority and
$5,000,000 from base resources) to states for 15 FERN laboratories; and,
- Completing the expansion of available data and providing needed security
and real-time communication features in eLEXNET, a food laboratory IT network
for the real time sharing of information on a national basis. eLEXNET supports
the FERN and can be interfaced appropriately with the public health IT systems.
Substantial strides during the past year have been made in the development
of eLEXNET.
Research
- Investing in the following types of research:
-- Prevention Technologies - FDA studies food prevention technologies
to improve the safety of food and establish guidelines and or performance
standards for industry. Information is needed about new technologies and
/ or technology enhancements that can increase food safety and protect against
potential exposure to non-traditional pathogens, toxins and chemicals during
possible high threat situations. For example, critical information is needed
to determine if prevention strategies such as changing pasteurization times
and temperatures could be used to safeguard foods and beverages while maintaining
the quality that the consumer expects;
-- New Methods - FDA fulfills its responsibility of ensuring the
safety of the food supply through reliance on surveillance and monitoring
methods. New microbiological, chemical, and radiological methods must be
developed, validated, and used to detect, enumerate and identify potential
non-traditional agents that may threaten the food supply. A particular emphasis
is the need to develop biosensors and other technologies that could permit
continuous monitoring of foods both during production and at import entry
sites;
-- Agent Characteristics - Additional assessments of the abilities
of non-traditional microbial pathogens to survive and grow in foods during
processing and storage, or the stability and activity of chemical agents
while present in foods, and the potential for their inactivation during
food processing are essential to improving FDA's ability to detect, quantitate
and control food borne pathogens, toxins and chemicals that threaten the
food supply; and,
-- Dose Response Relationships/Threat Assessments- An understanding
of the dosage amounts needed to inflict human disease or produce adverse
reactions, where exposure occurs through consumption of different food matrices,
is essential to accurately estimate the threat posed by such exposures.
In turn, knowledge of dose response helps determine methods development
performance parameters (e.g., sensitivity, ruggedness, statistical confidence)
that assure safety and security of the food supply.
Inspections, Bio-Surveillance, Incident Management
- Hiring more inspectors to increase inspectional coverage of domestic firms
and imported goods to reduce the risk of contaminated product entering domestic
commerce;
- Improving coordination and integration of existing food surveillance capabilities
with the Department of Homeland Security's integration and analysis function,
as part of the government-wide Bio-Surveillance Initiative; and,
- Continuing to expand FDA's capability for emergency preparedness and response,
related to any incident or emergency involving contamination of any FDA regulated
product. This would include preparing and responding to intentional acts of
contamination and significant public health emergencies. At the current time,
FDA has insufficient capacity to communicate in a secure environment with
its headquarters and field staff, especially during emergency situations.
The Emergency Operations Network Incident Management System project will allow
integrated access for all FDA offices to incident management, surveillance,
and alert information.
Administrative Efficiencies: - $6,774,000 and - 58 FTE
To fully embrace the President's Management Agenda, FDA is delayering its
organizational structure, performing competitive sourcing reviews, modernizing
its financial management system, and consolidating its information technology
infrastructure. The Foods portion of these management improvements consists
of -$6,774,000 and - 58 FTE.
PROGRAM ASSESSMENT RATING TOOL (PART)
In the FY 2004 review, FDA was assessed as five distinct programs (Foods,
Human Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological
Health) and was rated as "results not demonstrated" due to a lack
of long-term outcome goals. To address this concern, long-term outcome goals
were developed.
For FY 2005, the Office of Management and Budget conducted a second program
review that treated FDA as a single agency program. In this review, FDA received
a rating of "moderately effective" and score of 77 percent, up from
59 in FY 2004. This was due to considerable improvements in developing long-term
agency-wide outcome goals that will demonstrate its effectiveness and impact
on the public health. FDA also reduced the number of performance goals, and
made various management improvements that further streamline its infrastructure
while supporting core, mission-critical public health activities.
The Foods Program shares in an agency-wide outcome goal of reducing administrative
overhead through the reduction of the number of administrative staff. All of
the Agency's outcome goals support the Department's priorities and Administration's
initiatives with the intent to improve the health and well-being of the American
public.
JUSTIFICATION OF BASE
EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY
BUCK
Base resources will be used to conduct science-based risk management in all
agency regulatory activities so that the Agency's limited resources can provide
the most health promotion and protection at the least cost to the public. These
activities include efforts to:
- Continue FDA's national network of academic centers of excellence to strengthen
scientific standards for compliance and threat assessment and reduction;
- Continue to evaluate the CDC food borne disease outbreak surveillance system
data to identify and analyze outbreaks associated with FDA-regulated products,
for number of outbreaks, etiologic agents, morbidity and mortality, seasonality,
geographic location, site of food preparation, contributing factors and whether
the product is domestic or imported;
- Continue to develop food safety prevention standards and guidance to fill
the gaps in public health protection from farm to table---modernizing GMP's
for food establishments;
- Sustain enhancements to the strategic data systems for surveillance and
inspection activities of the food supply that help FDA inspectors focus on
and analyze products suspected to have microbiological and chemical contamination;
- Participate in national surveillance and emergency response programs, such
as the Food borne Disease Active Surveillance Network (FoodNet) and PulseNet.
FoodNet, a collaborative project with the CDC and USDA, conducts active surveillance
for food borne diseases and related epidemiology studies; PulseNet is a national
network of public health laboratories that performs DNA "fingerprinting"
on bacteria that may be food borne;
- Serve as project leader for the National Food Safety System (NFSS) by leading
an effort to improve coordination and communication among public health and
food regulatory officials, particularly around food borne illness outbreaks,
to more effectively implement existing food safety programs;
- Perform data cleanup on the Field Accomplishment and Compliance Tracking
System (FACTS) to improve the accuracy of our inventory of food firms; This
entails evaluating and standardizing poor quality data and resolving duplicates
-- then applying the same logic in real-time to incoming records from the
U.S. Customs Service and the FDA field force; and,
- Provide the operations and maintenance support necessary for the import
and domestic product monitoring equipment and information systems, and provide
rapid methods to test products in the field.
Domestic Inspections
Consumers rely on the FDA to prevent dangerous and unreliable products from
entering into commerce. Public safety and confidence could be jeopardized by
a failure to maintain levels of surveillance activities. The Foods Program needs
to sustain levels of laboratory analyses for chemical and microbiological contaminants
to meet public expectations. Base funding will enable FDA to:
- Conduct domestic inspections of food safety activities at the following
levels: 14,900 inspections conducted by FDA, and 10,200 inspections conducted
via state contracts or partnerships;
- Support deployed Radiation Emergency Response teams working with other Federal
and State agencies to monitor radiation threats to the food supply and provide
technical and food processing assistance;
- Achieve further adoption of the Food Code and continue to expand the percentage
of the total U.S. population covered by the Food Code;
What is the FDA Food Code?
The FDA publishes the Food Code, a model that assists food control jurisdictions
at all levels of government by providing them with a scientifically sound
technical and legal basis for regulating the retail and food service segment
of the industry. Local, state, tribal, and federal regulators use the
FDA Food Code as a model to develop or update their own food safety rules
and to be consistent with national food regulatory policy.
It also serves as a reference of best practices for the retail and
food service industries (restaurants and grocery stores and institutions
such as nursing homes) on how to prevent food borne illness. Many of the
over 1 million retail and food service establishments apply Food Code
provisions to their own operations. |
- Inspect at least 95 percent of the over 7,200 domestic firms that have been
identified as high-risk food establishments consisting of manufacturers, packers/repackers,
and warehouses processing products. These include: modified atmosphere packaged
products acidified and low acid canned foods, seafood, custard filled bakery
products, soft, semi-soft, soft-ripened cheese and cheese products, un-pasteurized
juices, sprouts or processed leafy vegetables, fresh vegetables shredded for
salads and processed root and tuber vegetables, sandwiches, prepared salads,
infant formula, and medical foods. Inspections will utilize associated laboratory
support for sample analysis;
- Identify the food source and contaminant of food borne illness outbreaks
ranging from chemical and microbiological, and/or physical hazards;
- Conduct state contract audit inspections to ensure consistent application
of regulations nationwide by FDA and the states;
- Continue to fund state contracts, partnerships and grants related to FDA-regulated
products so that FDA inspects and monitors the food industry frequently enough
to ensure application of appropriate preventative controls to ensure a safe,
wholesome, and nutritious food supply for compliance and inspection activities;
- Replace outdated field laboratory equipment to improve the accuracy and
timeliness of food product analyses to determine compliance with safety requirements;
- Provide criminal investigation of reported product tampering, counterfeit
products and other fraudulent criminal activities involving regulated products;
- Develop laboratory analytical methods to permit the analyses of products
for chemical and microbiological hazards; and,
- Continue to analyze more than 8,000 food samples for pesticides and environmental
contaminants.
Imports, Import Monitoring and Foreign Inspections
Products enter the U.S. through one of approximately 300 ports located throughout
the country. FDA relies on risk-based electronic screening of line entry data
that is produced by import filers in the Operational and Administrative System
for Import Support (OASIS) system to make the majority of entry decisions. The
food program adjusts the risk-based criteria to meet program priorities. In
FY 2005, FDA will be responsible for ensuring the safety of more than eight
million import line entries for food, food related, and cosmetic products. These
highly diversified entries include increasingly more products from countries
that are typically categorized as emerging economies, with start-up regulatory
infrastructures. FDA uses the OASIS data management and reporting system to
expedite import entry review, oversee importer and filer evaluation data integrity,
and follow-up on refused entries. Only a very small percentage of imported food
entries are directly inspected through field examinations and analyzed through
laboratory analysis. Thus, the safety of the U.S.food supply relies greatly
on export countries complying with U.S. safety standards. Given FDA's reliance
on third party oversight and compliance, it is in FDA's interest to enhance
the food safety systems in foreign countries and, thus, improve the quality
of imported food products. Base funding will:
- Maintain performance of physical exams at 60,000 and conduct sample analyses
on imported products with suspect histories; maintain performance of filer
evaluations at 1,000 for assessing the admissibility of regulated imported
articles;
- Maintain performance of examinations of FDA refused entries of food products
as they are delivered for exportation to ensure that the articles refused
by FDA are being exported;
- Continue to train import inspectors to enhance and streamline import sample
collection processes at ports of entry, which provide more rapid identification
of suspect agents;
- Modernize the import data system to enable better detection of tainted food,
and deter and detain food thought to be contaminated;
- Conduct foreign inspections, focusing on top priority high‑risk foods
so that the Agency can further assure that products offered for import are
safe, effective, and properly labeled; and, education/training to enhance
food safety systems in foreign countries and thus, improve the quality of
U.S.food imports;
- Continue to support operations and maintenance of OASIS to ensure continuity
of import operations in the event of a disabling threat to existing facilities,
until the existing system is replaced; and work with the U.S. Customs Service
to better leverage resources to strengthen efforts in detection and interdiction
of contaminated foods and enhance the safety of imported products through
surveillance at the border; and,
- Maintain the recent gains in the frequency and quality of imported food
inspections, and modernize the import data system to enable better detection
of tainted food, and to detain food suspected to be contaminated.
FDA Seizes Adulterated Honey
In 2003, at the request of the FDA, U.S. Marshals seized adulterated
imported bulk and finished product honey from a honey farm in Texas. U.S.
Marshals seized 266 drums of honey (each containing 639 pounds of bulk
honey) and five totes (each containing a net weight of 3,000 pounds) after
FDA tested and confirmed the presence of an unapproved food additive,
chloramphenicol. In accordance with the Federal Food, Drug and Cosmetic
Act, food products that contain chloramphenicol, an antibiotic, are
adulterated and are not permitted to be sold in or imported into this
country. The continued monitoring of food production and distribution
at many levels has enabled FDA to detect this adulterated honey since
the agency learned of the presence of chloramphenicol in imported honey.
Chloramphenicol is a broad-spectrum antibiotic drug used to treat life-threatening
infections in humans, usually when other alternatives are not available.
The use of this antibiotic is limited because of its potentially life-threatening
side effect, idiosyncratic aplastic anemia. For the very small number
of the population susceptible to this side effect, exposure to chloramphenicol
could be serious or life threatening. Because of the current uncertainty
regarding the dose-response relationship between chloramphenicol ingestion
and aplastic anemia, it is not possible to define a safe level for the
presence of this antibiotic in food products. The agency will continue
to detain or seize any honey imports that contain chloramphenicol to ensure
that this product is not released for human or animal consumption in the
United States. |
Dietary Supplements
The dietary supplement industry is now one of the world's fastest growing
industries with over 1,500 establishments claiming to manufacture dietary supplements
and sales of $17.1 billion in 2000. Between1994 and 2000, consumer spending
on dietary supplements nearly doubled, with over 158 million consumers, and
sales continuing to grow at more than 10 percent per year. Nearly 20 million
consumers use dietary supplements with prescription products. FDA is committed
to making safe products available to consumers, and has published a dietary
supplement strategy that sets clear program goals. It is a science-based regulatory
program that will fully implement the Dietary Supplement Health and Education
Act of 1994 (DSHEA). Base funding will enable FDA to:
- Respond to at least 95 percent of premarket notifications for new dietary
ingredients within the statutory time frame of 75 days;
- Review the 30-day postmarket notifications for structure and function claims
in a timely manner; and,
- Continue the collaborative effort on dietary supplement research with the
National Center for Natural Products Research in Oxford, Mississippi.
Bovine Spongiform Encephalopathy (BSE)
Bovine Spongiform Encephalopathy, or "Mad Cow Disease" is a deadly
chronic, degenerative disorder affecting the central nervous system. BSE and
Chronic Wasting Disease (CWD) both belong to a group of progressive degenerative
neurological diseases that are always fatal, known as transmissible spongiform
encephalopathies (TSEs). There are several TSE diseases that affect humans and
the best known is Creutzfeldt-Jakob disease (CJD). Potential products regulated
by FDA's Foods Program that can contain these substances are ruminant protein-containing
cosmetic products that are packaged and ready for sale, and bovine-derived materials
intended for human consumption as either finished dietary supplement products,
or for use as ingredients in dietary supplements. Base funding will enable FDA
to:
- Continue to identify food and cosmetic products containing brain, spinal
cord, and other specific risk materials, including the origin of the animal
and country, and infectious agents in foods;
- Conduct any necessary standard setting or compliance activities relating
to BSE that may include, if appropriate, the development of proposed and final
rules concerning the ban of bovine prohibited materials from cosmetics, dietary
supplements, food additives, infant formula and all other food products; and,
the re-evaluation of certain gelatin products;
- Conduct research on decontamination or deactivation procedures;
- Conduct research on BSE recovery and identification methods from foods and
cosmetics; and,
- Conduct research on the risk factors and mechanism for Chronic Wasting Disease
(CWD), which affects elk, deer and other domestic game or pen-reared animals.
International Activities
It is important that FDA leverage scarce resources with the international community
to provide benefits and incentives for all participants while accomplishing
the Agency's foods mission of ensuring the safety of the domestic food supply.
FDA will participate in, and raise visibility in, 18 Codex Committees and Task
Forces. There are 13 meetings scheduled on a wide variety of products, one meeting
of the Codex Commission and an estimated four working groups arising from the
various Codex Committees and Task Forces. These meetings ensure that source
country standards, quality systems, and audits conform to the requirements of
the Federal Food, Drug, and Cosmetic Act.
Premarket Activities
FDA focuses premarket resources to provide for scientifically sound and timely
reviews of the safety of food and color additives and food contact substances
prior to their entry into the marketplace. To accomplish this, FDA needs to
continue to improve the scientific knowledge base that will lead to safer food
products and to a better understanding of the complexities of the products the
agency regulates. The FDA Modernization Act established a notification process
for food contact substances. Since the premarket notification program became
fully operational in January 2000, many of the simpler food additive petitions
that could have been completed within 360 days are now being handled under the
notification program as food contact substance notifications, thus decreasing
the workload for this goal. However, since the remaining petitions are usually
more complex and time-consuming ones, the Agency anticipated that performance
on this goal could decline initially. Once the notification and the recent improvements
to the petition review process are well established, FDA expects performance
on this goal to increase substantially toward full performance in succeeding
years. With base funding, FDA will:
- Continue to reduce the possibility of food-related deaths or injuries and
improve the health and well-being of consumers by ensuring that decisions
related to approvals of petitions and notifications are scientifically justified
and benefit the public health;
- Continue to develop premarket review standards for new products and emerging
technologies such as antimicrobial ingredients used in the preparation of
processed foods, address the human food safety aspects of genetically modified
foods, address the use of novel ingredients added to conventional foods, and
ingredients new to infant formulas and medical foods;
- Continue to improve the premarket review process for food and color additives
using advanced computer and telecommunications technologies;
- Complete review and action on the safety evaluation of 75 percent of food
and color additive petitions within 360 days of receipt;
- Continue to provide pre-filing assistance to petitioners through the publication
of detailed guidance for food contact substances and food and color additives;
and,
- Review 95 percent of premarket notifications for food contact substances
within the statutory time limit of 120 days.
Other Program Activities
Under the Federal Food, Drug, and Cosmetic Act, Section 704, FDA is granted
general authority to inspect food establishments, and under FFD&C Act Section
903, the Agency shall be responsible for research relating to foods and cosmetics
in carrying out this Act. FDA will:
- 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;
- Continue to evaluate the risks of pesticides and chemical contaminants,
and the level of food nutrients in the U.S.diet, based on the revised FDA
Total Diet Program. Data will provide information on levels of pesticides,
industrial chemicals, toxic elements, and vitamins and minerals in foods that
is more representative of today's consumer eating habits; and,
- Continue to advance FDA's egg safety, as well as other compliance and enforcement
programs, by continuing research on egg safety as well as education and outreach
activities on the proper handling, storage and cooking of eggs. FDA also continues
to implement all enforcement efforts of the rule on egg refrigeration/temperature
and labeling.
Information Technology
CFSAN Adverse Events Reporting System (CAERS): CFSAN has developed a
comprehensive system for tracking and analyzing adverse event reports involving
foods, cosmetics and dietary supplements. The CFSAN Adverse Events Reporting
System (CAERS) replaces the patchwork of adverse event systems that were maintained
by individual Offices within CFSAN. CAERS will be used as a monitoring tool
to identify potential public health issues that may be associated with the use
of a particular product already in the marketplace. Information gathered in
CAERS will also assist FDA in the formulation and dissemination of CFSAN's post-marketing
policies and procedures. CAERS database went "live" in June 2003, and the first
"version" is now being employed by its users. In this first version, all new
consumer complaints and new adverse reports received after June 15, 2003, are
recorded into the system and all complaints and adverse reports are reviewed
by CAERS' medical staff. Additionally, industry outreach is achieved by sending
a letter to the manufacturer informing them of the receipt of an illness or
injury in the adverse report alleged to be caused by their product. CAERS will
also be investigating ways to capture increased numbers of adverse events, in
order to improve post-marketing surveillance on CFSAN regulated products. CAERS
continues to undergo enhancements, development, and maintenance to improve the
system based on user needs and collaborative efforts. Additionally, as funds
become available, CAERS plans to improve data links with other Adverse Events
Reporting Systems and other food injury reporting systems and enter older adverse
reports into its database.
Food Additives Regulatory Management (FARM): FARM provides information management
tools for food additive petition reviewers to maximize productivity and expedite
the petition review process and subsequent safety decisions. This comprehensive
image-based electronic document management and workflow automation system also
helps FDA perform associated activities such as responding and managing Freedom
of Information requests and correspondence. All paper and electronic documents
are converted to standard formats and stored in a well-organized electronic
document management system. Each reviewer will be able to retrieve documents
at their desks using a combination of attribute and full-text search capabilities
supported by a thesaurus maintaining nomenclature control.
EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION
Base resources will be used to better enable consumers to make informed decisions
weighing benefits and risks of FDA-regulated products. FDA will:
- Continue to implement the Consumer Health Information for Better Nutrition
initiative which seeks to make available more and better information about
foods and dietary supplements, to help American consumers prevent diseases
and improve their health by making sound dietary decisions;
- Continue to participate in the FDA Task Force on Consumer Health Information
for Better Nutrition; This task force is developing a framework to help consumers
obtain accurate, up-to-date, and science-based information about conventional
food and dietary supplements; This includes the development of additional
scientific guidance on how the "weight of the evidence" standard will be applied,
as well as the development of regulations that will give these principles
the force and the effect of law;
- Continue task force efforts to encourage makers of conventional foods and
dietary supplements to make accurate, science-based claims about the health
benefits of their products, and to help eliminate bogus labeling claims by
taking on those dietary supplement marketers who make false or misleading
claims;
- Continue to strengthen enforcement actions against dietary supplements that
make false or misleading claims as well as an aggressive enforcement strategy
against such claims;
- Host bi-monthly Health Fraud Coalition Conference Calls (members include
National Association of Attorneys General, FDA, FTC, Health Canada, and Mexico);
and,
- Ensure enforcement activities focus on products with specific marketing
strategies. These products include: dietary supplements and unsubstantiated
structure function claims; examples include treatment for autism, treatments
for mental retardation and epilepsy, sports performance enhancement, and aging;
and dietary supplements containing prescription drug ingredients.
IMPROVING PATIENT AND CONSUMER SAFETY
Base resources will be used to promote improved patient and consumer safety
by reducing risks associated with FDA-regulated products. The Foods program
will continue to enhance FDA's Adverse Event Reporting Systems, which are designed
to compile and assess large numbers of physician, health professional data and
conclusions and provide likely associations and causative agents for follow‑up
through investigation and clinical testing. CAERS (also under Efficient Risk
Management) will integrate its multiple adverse event reporting systems currently
in existence, including the current system for dietary supplements.
In December of 2003, FDA issued a consumer
alert on the safety of dietary supplements containing ephedra. The alert
advised consumers to immediately stop buying and using ephedra products. Ephedra,
also called Ma huang, is a naturally occurring substance derived from plants.
Its principal active ingredient is ephedrine, which when chemically synthesized
is regulated as a drug.In recent years ephedra products have been extensively
promoted to aid weight loss, enhance sports performance, and increase energy.
FDA also notified
manufacturers that it intends to publish a final rule stating that dietary
supplements containing ephedrine alkaloids present an unreasonable risk of illness
or injury. The rule would have the effect of banning the sale of these products
as soon as it becomes effective, 60 days after publication;
PROTECTING AMERICA FROM TERRORISM
Base resources will be used to strengthen FDA's capability to identify, prepare
for, and respond to terrorist threats and incidents.
Defense of the U.S. Food Supply
The events of September 11, 2001, heightened the nation's awareness and
placed a renewed focus on ensuring the protection of the nation's critical
infrastructures. A terrorist attack on the food supply could pose both
severe public health and economic impacts, while damaging the public's
confidence in the food we eat. Several food incidents since the fall of
2001 highlight the significance of FDA's food defense activities. In the
fall of 2002, a competitor of a restaurateur in China added a chemical
compound to his competitor's food and killed dozens of people and sent
hundreds more to hospitals. Also in the fall of 2002, three individuals
were arrested in Jerusalem for allegedly planning to carry out a mass
poisoning of patrons at a local café. One of the arrested individuals
worked as a chef at the café. In January 2003, several individuals
were arrested in Britain for plotting to add Ricin to the food supply
on a British military base. Each of these incidents shows the potential
for the nation's food supply to be used in an attack. FDA, at the direction
of the Department of Health and Human Services, has established a 10-Point
Program for ensuring the safety and security of the food supply. Based
on this, FDA is employing overall strategies to (1) develop increased
awareness among federal, state, local, and tribal governments and the
private sector by collecting, analyzing, and disseminating information
and knowledge (Awareness); (2) develop capacity for identification of
a specific threat or attack on the food supply (Prevention); (3) develop
effective protection strategies to "shield" the food supply from terrorist
threats (Protection); (4) develop capacity for a rapid, coordinated response
to a food borne terrorist attack (Response); and (5) develop capacity
for a rapid, coordinated recovery from a food borne terrorist attack (Recovery). |
Food Safety and Security
The Foods Program helps to protect the safety of the U.S. food supply by targeting
efforts to minimize health and safety risks facing the U.S. public, and by quickly
and accurately assessing and effectively managing those risks. FDA must work
to develop profiles of possible or probable food threats and points of attack
and must have the capacity to quickly and accurately identify potential or actual
outbreaks at any point in the food chain, and take prompt action to mitigate
their effects. Base funding will enable FDA to:
State Contracts/Grants
- Maintain the number of state partnerships and grants related to FDA-regulated
products for FDA to continue to inspect and monitor the food industry frequently
enough to ensure application of appropriate preventative controls to ensure
a safe, wholesome, and nutritious food supply for compliance and inspection
activities; and,
- Maintain FDA's presence in its retail, state audits and targeted inspection
activities, and increased state partnerships and grant activities;
Laboratory Preparedness
- Continue the development of methods science within FDA to support the critical
infrastructure needed for the FERN, which will provide integrated laboratory
solutions and disseminated testing capacity to support public health preparedness
and response to an act of Bio terrorism involving the food supply;
- Continue the laboratory accreditation program covering all Center foods
facilities to harmonize practices in food laboratories conducting regulatory
testing to ensure acceptance of FDA laboratory results throughout the world
(this will include enhanced data quality systems and support for instrument
validation);
- Continue to develop uniform scientific practices for accreditation of FDA's
general-purpose and specialty field labs to the international standard for
regulatory sample analysis;
- Continue the upgrade of field laboratory capabilities to rapidly detect
Bio terrorism contamination;
- Continue diagnostic tests to produce tools that are needed for field and
import examinations to determine if a product has been tampered with or is
otherwise tainted;
- Continue to expand, by 25 for a total of 104, the number of state health
and agriculture laboratories and capabilities of current laboratories connected
to the eLEXNET. This expansion will allow the laboratories to exchange data
on select biological agents (possibly including anthrax, botulinum toxin,
brucellosis and other potential infectious diseases) and food pathogens and
assist in the Department's Counter terrorism efforts. This system is the first
Internet-based food safety system that consolidates a repository of pathogenic
findings in the nation's food supply by Federal, state, and local government
labs, and will link state and local organizations with the Federal partners
to respond more quickly to outbreak situations;
- Continue enhanced efforts in rapid analysis of suspect foods to asses for
biological and chemical agents that could be intentionally introduced into
a food;
- Develop preventative standards, education campaigns and research to improve
food safety and security through rapid tests of detection and reduction;
- Streamline techniques for the rapid detection and assessment of bacterial
strains of bio terrorist agents (pathogens/chemicals); and,
- Provide technical assistance to develop irradiation techniques and methods
to kill anthrax spores in the mail by participating with industry, which already
uses irradiation to sanitize poultry, ground beef, spices, and medical equipment.
Prior Notice and Foods Registration System
- Continue regulatory guidance in an expedited time period in order to implement
Title III of the Bio terrorism Act. The FDA is required to propose and issue
final regulations for the following four provisions: Section 305 (Registration
of Food Facilities); Section 306 (Establishment and Maintenance of Records);
Section 307 (Prior Notice of Imported Food Shipments); and Section 303 (Administrative
Detention); and,
- Maintain the Food Registration and Prior-Notice system.
FDA Unified Registration and Listing System
Under the stringent time constraints mandated by the Bio terrorism Act
of 2002, FDA fully implemented an on-line Food Facility Registration Module
which is capable of handling 5,000 on-line registrations, (required from
domestic and foreign facilities that manufacture/process, pack, or hold
food for human or animal consumption in the United States), simultaneously
via the Internet. In addition to responding to these requirements, FDA
provided unified account management and single on-line entry point to
be used for all of FDA Listing systems. As specified under the Bio terrorism
Act, a paper process, including a paper processing facility, has been
established to accept registrations via mail, fax, etc. to enter these
into the electronic system, and to respond via paper to facilities doing
business utilizing paper forms. |
Information Technology
FDA Unified Registration and Listing System: The Unified Registration
and Listing System (FURLS) supports the requirements of the Bio terrorism Act
of 2002 as it relates to Food Facility Registration, Drug Facility Registration
and Listing, and Prior Notice of Food Shipments into the United States. FDA
began the FURLS effort by identifying opportunities for unification between
the FDA Drug Facility Registration and Listing requirements with those of the
Food Facility Registration Requirements.
Electronic Laboratory Exchange Network (eLEXNET): eLEXNET is the nation's
first Internet-based data exchange system that allows Federal, State, and local
laboratories to electronically share food safety sample and test data for various
food-borne pathogens. The laboratories are able to access eLEXNET, regardless
of their current system environment or level of automation.
SELECTED FY 2003 ACCOMPLISHMENTS
EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY
BUCK
Imports and Foreign Inspections
- FDA completed 78,659 field examinations of imported food shipments, exceeding
the goal of 48,000 by 64 percent. This is more than a five-fold increase from
the 12,000 field import examinations conducted in FY 2001.
Domestic Inspections
- In conjunction with the states, FDA conducted 7,363 domestic inspections
of firms that produce "high risk" foods exceeding our performance
goal of 6,650 establishments. The field performed more high risk inspections
than the target (7,200) because of changes in the risk category of firms between
the time that the inventory was calculated and when the inspections were conducted.
The food firm inventory and firm risk categories change even when the overall
totals appear stable. The field often needs to perform more firm inspections
than the target to be sure of meeting the high risk target.
Fruits and Vegetables
- Developed a strategy for addressing the multiple outbreaks of E. coli 0157:H7
from contaminated lettuce. The strategy calls for working with industry to
collect specific information to fill in gaps such as using a questionnaire
on lettuce-specific practices to see if any patterns emerge. The strategy
also includes research, both basic and applied. Based on information gained,
the strategy calls for identifying interventions to avoid or minimize contamination
in the field or packing houses, to treat lettuce post-harvest, and education/outreach
relative to safer production practices. Some of these actions have already
been initiated; and,
- FDA and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
conducted a train-the-trainer program on Good Agricultural Practices and Good
Manufacturing Practices (GMP's) for the production of fresh produce from September
12 - 20, 2003 at the Cummunidad Andina in Lima,Peru. Participants included
selected growers, state and federal officials, and consultants from Peru,
Venezuela, Equador, Bolivia, and Columbia. Participants were trained in good
agricultural and manufacturing practices, with lectures, case studies, practical
exercises, and an overview of FDA's registration, record keeping, and prior
notice proposed rules implementing the Bio terrorism Act of 2002. Participants
took part in an extensive, commodity specific, farm exercise based on conditions
realistic for the region. An examination, administered on the last day, resulted
in a class average of 92 percent.
Cooperative Programs
- At the end of FY 2003, forty-two states and territories that together represents
76 percent of the U.S. population, had adopted codes patterned after either
the 1993, 1995,1997,1999 or 2001 versions of the Food Code. This meets our
goal for FY 2003.
Transmissible Spongiform Encephalopathies (TSEs)
- Worked with both USDA's APHIS and FSIS to effectively respond to the BSE
situation in Canada. For approximately a month after the May discovery of
a cow in Canada with BSE, FDA and USDA had daily interagency phone calls to
coordinate response to the situation. When the daily calls were no longer
considered necessary, the agencies agreed to continue to communicate as needed
to ensure that we respond as one government to the Canadian situation. FDA
is currently in discussions with APHIS about what would be needed to allow
import of additional bovine commodities from Canada.
Food Allergens
- Created an Allergen Inspection Database. FY 2002 Establishment Inspection
Reports (EIRs) have been coded and entered into the database. CFSAN successfully
completed the evaluation and summarization of the data from 500 allergen inspections
conducted in FY 2002.
Food Safety
Food and Color Additives
- For the petition receipt cohort of FY 2002, completed within 360 days of
filing, the safety evaluation of three of the three food additive petitions
that qualify for expedited review. A petition qualifies for expedited review
if the food additive is intended to decrease the incidence of foodborne illnesses
through its antimicrobial actions against human pathogens that may be present
in food;
- For the petition receipt cohort of FY 2002, completed within 360 days of
filing, the safety evaluation of six of the eight (75 percent) food and color
additive petitions that do not qualify for expedited review. This meets our
goal of completing at least 70 percent of these petitions within 360 days;
- Completed the evaluation of all (3) biotechnology final consultations received
in FY 2002;
- Completed processing of 28 of 30 (93 percent) GRAS Notifications received
in FY 2002 within 180 days. This exceeds our goal of completing at least 80
percent of GRN’s within 180-day statutory timeframe;
- Completed review of all 111 Food Contact Notifications within 120-day statutory
timeframe;
- Drafted a Report to the Appropriations Committee that provides an estimate
of the costs of carrying out the premarket notification program. The report
is currently going through Administration clearance;and,
- On August 26th and 27th FDA convened a meeting of the Additives and Ingredients
Subcommittee of its Food Advisory Committee to assist in gathering information,
and to get independent expert consideration of questions that FDA has raised
regarding natural rubber latex (NRL) allergy as it relates to food safety.
In accordance with Title 21 CFR 177.2600 Rubber articles intended for repeated
use, natural rubber is an approved indirect food additive when used as a component
of a repeat-use, food-contact article such as a food-service glove. Nevertheless,
FDA has received reports of latex allergic individuals experiencing allergic
reactions to foods believed to have been prepared by workers wearing NRL food-service
gloves. FDA has been gathering and analyzing information from a variety of
sources relating to the incidence of food-mediated latex allergic reactions
and presented that information to the Additives and Ingredients Subcommittee.
During the two day meeting, the Subcommittee heard from a variety of sources,
including experts from Center for Devices and Radiological Health and Center
for Biologics Evaluation and Research, as well as experts from outside of
FDA. The Subcommittee reached a consensus that a potential hazard may exist,
but concluded that the science establishing a risk from the use of NRL food-service
gloves is very weak. The committee recommended that FDA consider establishing
specifications for food service gloves (for example, residual protein and/or
donning powder levels) to address the potential hazard, and that well-designed
clinical studies would be helpful to better understand the levels of exposure
that would be required to elicit a systemic response in a latex allergic
individual.
Seafood Safety
- In our strategy to increase above the level of 85 percent the number of
seafood processors that are in compliance with the seafood HACCP program,
CFSAN has: continued prioritization in the compliance program of inspections
of processors in industry sectors that lag behind in HACCP implementation
and continued prioritization of inspections of processors that lack HACCP
plans; issued to districts lists of the firms that still did not have HACCP
plans to help the districts target inspections toward such firms; and, developed
a research plan to develop a better understanding of what proper controls
should look like in industry sectors that lag behind in HACCP implementation.
What is HAACP?
HACCP involves seven principles:
Analyze hazards. Potential hazards associated with a food and measures
to control those hazards are identified. The hazard could be biological,
such as a microbe; chemical, such as a toxin; or physical, such as ground
glass or metal fragments.
Identify critical control points. These are points in a food's production--from
its raw state through processing and shipping to consumption by the consumer--at
which the potential hazard can be controlled or eliminated. Examples are
cooking, cooling, packaging, and metal detection.
Establish preventive measures with critical limits for each control point.
For a cooked food, for example, this might include setting the minimum
cooking temperature and time required to ensure the elimination of any
harmful microbes.
Establish procedures to monitor the critical control points.Such procedures
might include determining how and by whom cooking time and temperature
should be monitored.
Establish corrective actions to be taken when monitoring shows that a
critical limit has not been met -- e.g., reprocessing or disposing of
food if the minimum cooking temperature is not met.
Establish procedures to verify that the system is working properly--for
example, testing time-and-temperature recording devices to verify that
a cooking unit is working properly.
Establish effective record keeping to document the HACCP system.This
would include records of hazards and their control methods, the monitoring
of safety requirements and action taken to correct potential problems.
Each of these principles must be backed by sound scientific knowledge:
for example, published microbiological studies on time and temperature
factors for controlling foodborne pathogens. |
Why is HACCP Needed?
New challenges to the U.S.food supply have prompted FDA to adopt a HACCP-based
food safety system on a wider basis. One of the most important challenges
is the increasing number of new food pathogens. For example, between 1973
and 1988, bacteria not previously recognized as important causes of food-borne
illness--such as Escherichia coli O157:H7 and Salmonella enteritidis--became
more widespread. There also is increasing public health concern about
chemical contamination of food: for example, the effects of lead in food
on the nervous system. Another important factor is that the size of the
food industry and the diversity of products and processes have grown tremendously--in
the amount of domestic food manufactured and the number and kinds of foods
imported. At the same time, FDA and state and local agencies have the
same limited level of resources to ensure food safety. The need for HACCP
in the United States, particularly in the seafood and juice industries,
is further fueled by the growing trend in international trade for worldwide
equivalence of food products and the Codex Alimentarious Commission's
adoption of HACCP as the international standard for food safety. |
Chemical Contaminants, Pesticides and other Hazards
- Completed the development phase of its action plan by presenting and receiving
advice on the plan from FDA's Food Advisory Committee and the Contaminants
and Natural Toxicants Subcommittee of the Food Advisory Committee. Implementation
of this action plan has begun by completing the preliminary or exploratory
survey on acrylamide occurrence in foods and acrylamide analyses of FDA's
FY/03 Total Diet Study Survey food samples. Major studies on acrylamide formation
in foods and on toxicology and health effects, as outlined in the action plan,are
underway at FDA, CDC, and NIH;
- Announced on July 22, 2003the availability of a level 1 draft guidance for
industry entitled: "Channels of Trade Policy for commodities with
Residues of Pesticide Chemicals, for which Tolerances have been Revoked, Suspended,
or Modified by the Environmental Protection Agency" (EPA). This guidance
is intended to present general policy on FDA's planned enforcement approach
for foods containing such residues in accordance with the provision in section
408(1)(5) (the "channels of trade provision") of the Federal Food
and Drug and Cosmetics Act, as amended by the Food Quality Protection Act
(FQPA);
- Collected and analyzed 11,331 food samples for pesticides and chemical contaminants,
exceeding our goal by 3,331 or 142 percent of our intended target; and,
- Published a proposed rule and direct final rule for radionuclides quality
standards for bottled water on march 3, 2003 This final rule will ensure
that the minimum quality of bottled water --as affected by uranium, combined
radium-226/-228, gross alpha particle radioactivity, and beta particle and
photon radioactivity --remains comparable with the quality of public drinking
water that meets the EPA's standards.
EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION
Education
- FDA sponsored a regional outreach meeting on food safety and security that
was held in Buenos Aires , Argentina on September 1st and 3rd. Three hundred
representatives from 10 nations in South America participated. The U.S. delegation
consisted of representatives from FDA, USDA's FSIS, the CDC, and Department
of Homeland Security/Customs Border and Protection (CBP). The program consisted
of presentations on U.S. food safety and security programs, U.S. import requirements,
and concurrent sessions on regulations and guidance for specific commodities
(including produce, seafood, juice, dairy and egg products, meat and poultry.
The delegation hosted a press conference to discuss the meeting and to report
progress on the implementation of the Bio terrorism Act and participated in
a field trip to a food distribution warehouse in Buenos Aires, and a dairy
processing plant outside the city. A regional dairy processing safety program
was held in Montevideo ,Uruguay immediately following the meeting in Argentina
. Trainers included representatives from CFSAN, the Center for Veterinary
Medicine and ORA. In addition to a review of how dairy products are regulated
in the United States and a review of best practices, the trainers provided
an update on the progress of the new Bio terrorism regulations. Over 150 representatives
from 10 nations participated. The response to both meetings was overwhelmingly
positive.
- FDA launched a public education campaign targeted to Hispanic men on the
risks from Vibrio vulnificusin raw oysters in the summer of 2003. Facets of
the campaign included a partnership with community-based health organizations
and outreach through the Hispanic media. FDA provided information in the form
of a fotonovela (illustrated storybook that shows what may happen if people
with weakened immune systems eat raw oysters contaminated with Vibrio vulnificus)
and by distributing public service announcements. This Education Campaign
was carried-out through Hispanic media nationwide (i.e., news paper, radio,
and television) with special emphasis in Florida and Texas media. This effort
reached an audience of over 3 million people.
Nutrition, Health Claims and Labeling
- FDA published Guidance for Industry titled: "Qualified Health Claims
in the Labeling of Conventional Foods and Dietary Supplements" on December
20, 2002. This document updates the Agency's approach to implementing the
court of appeals decision in Pearson v. Shalala (Pearson)to include conventional
foods and provides guidance to industry on the circumstances under which FDA
will consider exercising its enforcement discretion for health claims that
do not meet the "significant scientific agreement" standard of evidence.
- This document also describes the process that FDA intends to use to respond
to future health claim petitions. Finally, the document clarified that the
Agency will use the "reasonable consumer" standard in evaluating
food labeling claims.
- The FDA Task Force on Consumer Health Information for Better Nutrition issued
its report on July 10, 2003. The report contains the following guidance documents
and publications:
-- A guidance document entitled "Interim Evidence-based Ranking
System for Scientific Data"; A Notice of Availability about FDA's
guidance on qualified health claims was published in the Federal Register
on July 11, 2003;
--A report entitled, "Interim Procedures for Qualified Health Claims
in the Labeling of Conventional food and Human Dietary Supplements",which
sets the procedures FDA will use for the timely review of qualified health
petitions, beginning September 2003;These procedures are intended to be
interim until such time as notice-and-comment rulemaking for a qualified
health claim petition regulatory framework is completed;
-- A report entitled "Possible Regulatory Framework for Qualified
Health Claims in the Labeling of Conventional Human Food and Human Dietary
Supplements", which presents a framework for proposed regulation
of qualified health claims;This document developed three regulatory alternatives
for consideration and comment;and,
-- A report on July 10, 2003, entitled "Consumer Studies Research
Agenda -- Improving Consumer Understanding and Product Competition on the
Health Consequences of Dietary Choices",which presents a description
of proposed consumer research studies and a timeline for peer review of
the protocol as well as OMB approval;
FDA Task Force on Consumer Health Information for
Better Nutrition
In2003, FDA announced the establishment of the Task Force on Consumer
Health Information for Better Nutrition. The Task Force is charged to
provide recommendations to develop new procedures for the review of qualified
health claims and to propose a consumer studies research agenda within
six months. Under the leadership provided by FDA's Task Force, whose report
was made public on July 10, 2003, FDA published guidance extending applicability
of qualified health claims to conventional foods; established a process
for reviewing qualified health claim petitions; developed scientific guidance
for industry on evidence-based ranking of scientific evidence for such
claims; established a consumer studies research agenda; and increased
enforcement against unsubstantiated dietary supplement claims. FDA also
published a final rule to require labeling of trans fat, the first major
change to the Nutrition Facts panel in a decade. |
- Completed the review of fifty-four pre-market notifications for new infant
formulas, with objections given for only one. All were completed within the
statutory timeframe;
- Reviewed and issued decisions on 10 nutrient content and health claim petitions.
Of these, four claims were denied, regulations were published for two claims,
and four other claims were permitted as qualified health claims by exercise
of enforcement discretion;
- Prepared and transmitted a report to Congress explaining the Agency's initiative
to make available to consumers more and better information about the health
benefits of foods and dietary supplements. House Report 107-623 of the Agriculture,
Rural Development, FDA and Related Agencies 2003 Appropriations Language directed
FDA to consider the health claim that "consumption of omega-3 fatty acids
in salmon can prevent and reverse heart disease." This initiative will include
consideration of a qualified health claim on omega-3 fatty acids for conventional
foods such as salmon;
Revealing Trans Fats to Reduce Risk of Coronary
Heart Disease
In 2003, CFSAN published final regulations requiring food manufacturers
to list Trans Fat on Nutrition Facts panels by January 1, 2006. This additional
information will give consumers a more complete picture of fat content
in foods -- allowing them to choose foods low in saturated fat, trans
fat, and cholesterol -- all of which raise LDL ("bad") cholesterol
that increase the risk of coronary heart disease (CHD). Along with saturated
fat and cholesterol, trans fat on the food label gives consumers information
needed to make food choices that help reduce the risk of CHD. This revised
label will be of particular interest to people concerned about high cholesterol
and heart disease.
According to the National Heart, Lung, and Blood Institute of the NIH,
more than 12.5 million Americans have CHD, and more than 500,000 die each
year-- making CHD one of the leading causes of death in the U.S. Increasing
the understanding of consumers regarding the impact of dietary choices
on risk of CHD is a key FDA goal (i.e., "Better Informed Consumers")
in addressing this public health threat. The labeling of Trans fats is
a key part of this effort. |
- Issued an advance notice of proposed rulemaking (ANPRM) in the Federal Register
to solicit information and data that could be used to establish new nutrient
content claims about trans fat on July 11, 2003. The ANPRM also solicited
information and dates to establish qualifying criteria for trans fat in existing
claims that have a limit on saturated fat and health claims that contain a
message about cholesterol-raising lipids. The ANPRM requests comment on whether
we should consider statements as footnotes in the Nutrition Facts panel or
in conjunction with claims to enhance consumers' understanding about how to
use the information to make heart-healthy food choices;
- Published in the Federal Register a proposed rule to amend the regulation
for sodium levels for foods that use the nutrient content claim "healthy"
on February 20, 2003. The proposal establishes sodium levels for the definition
of "healthy" that are not so restrictive as to preclude the use
of the term "healthy", and not so broadly defined as to cause the
term to lose its value in identifying useful products for constructing a healthful
diet. The Agency based the proposed sodium requirements on the presumption
they represent levels that are achievable by manufacturers, but sufficiently
restrictive to provide consumers with a meaningful definition of the term
"healthy" that will asses them in constructing a diet consistent
with dietary guidelines;
- Published in the Federal Register a proposed rule to reopen the comment
period for the proposed rule, published in the Federal Register of July 9,
1996, revising its infant formula regulations.The proposed rule would establish
requirements for current good manufacturing practice (CGMP) and audits, establish
requirements for quality factors, and amend its quality control procedures,
notifications, and records and report requirements for infant formula. FDA
is reopening the comment period to update comments and to receive any new
information;
- Convened the Infant Formula Subcommittee of the Food Advisory Committee
on November 18-19, 2003. The meeting's purpose was to discuss the scientific
issues and principles involved in assessing and evaluating whether a "new"
infant formula supports normal physical growth infants when consumed as a
sole source of nutrition.This was the second meeting of a series of advisory
committee meetings to discuss the scientific issues involved in evaluating
whether a new infant formula supports normal physical growth; and,
- Convened the Contaminants and Natural Toxicants Subcommittee of the FDA
Food Advisory Committee on March 18-19, 2003. The purpose of the meeting was
to discuss the scientific issues and principles involved in assessing and
evaluating Enterobacter sakazakii contamination in powdered infant
formula, risk reduction strategies based on available data, and research questions
and priorities.
IMPROVING PATIENT AND CONSUMER SAFETY
Dietary Supplements
- Filed and responded to 58 notifications for dietary supplements containing
new dietary ingredients within the 75 day period. The notifications are reviewed
for science-based evidence of safety. Letters are issued to the notifier to
acknowledge receipt and, when necessary, to identify deficiencies and safety
concerns;
- HHS and FDA announced a series of actions designed to protect Americans
from the potentially serious risks of dietary supplement products containing
ephedra/ephedrine on February 28, 2003. Among these actions, FDA proposed
a new warning label for all ephedra-containing dietary supplements. In seeking
comments on the new warning label and other issues, FDA reopened a proposed
rule entitled: "Dietary Supplements Containing Ephedrine Alkaloids".
The comment period of the proposed rule has ended;
- Announced a significant enforcement initiative targeted at misleading claims
about dietary supplement-associated health benefits on December 18, 2002.
Over the last six months, the FDA issued 73 warning letters and cyber letters
to marketers of dietary supplement products; seized products worth almost
$9 million; refused import of 368 shipments of dietary supplement products
offered for entry; and supervised the voluntary destruction of $515,000 worth
of dietary supplements promoted with unsubstantiated structure/function claims;
and,
- Worked with the FTC with the mutual goal of consumer protection, and formed
a Dietary Supplement Enforcement Working Group to closely coordinate their
enforcement efforts against health care fraud. In addition, FDA and FTC chair
an interagency health fraud steering committee that meets regularly to coordinate
activity on these issues. The workgroup currently includes federal agencies
in the U.S. and Canada. Mexico has been invited to join the group.
Cosmetics
- Announced, on December 2, 2002, the availability of a draft guidance document
entitled "Labeling for Topically Applied Cosmetic Products Containing
Alpha Hydroxy Acids as Ingredients". This draft guidance is intended
to provide the cosmetic industry with suggested wording for a label statement
alerting consumers to the possibility of increased skin sensitivity, particularly
sunburn, associated with the use of such products, as well as protective measures
to use; and,
- Developed a web-based, online, interactive registration system with which
manufacturer, repackers and distributors of cosmetic products can register
their cosmetic formulations. The system also will allow industry to update
and/or discontinue old formulations.
Other
FDA continues its food processing and packaging research and outreach
programs at the National Center for Food Safety and Technology (Moffett Center)
in Illinois, with a focus on contemporary food safety and security issues. The
application for the cooperative agreement supporting NCFST has been received
from the Illinois Institute of Technology, reviewed,approved, and the funding
provided. NCFST is significantly expanding its research program through the
development of a BSL-3 level laboratory and conduct of critical research to
enhance food security, particularly in assessing food technologies that can
reduce this risk.
PROTECTING AMERICA FROM TERRORISM
Implementation of Bio terrorism Legislation --
Registration and Prior-Notice
FDA published an interim final regulation that requires domestic and
foreign facilities that manufacture/process, pack, or hold food for human
or animal consumption in the United States to register with FDA by December
12, 2003. The interim final rule implements the Public Health Security
and Bio terrorism Preparedness and Response Act of 2002 (the Bio terrorism
Act), which requires domestic and foreign facilities to register with
FDA by December 12, 2003, even in the absence of a final regulation. Registration
is one of several tools that will enable FDA to act quickly in responding
to a threatened or actual terrorist attack on the U.S.food supply by giving
FDA information about facilities that manufacture/process, pack, or hold
food for consumption in the United States. In the event of an outbreak
of foodborne illness, such information will help FDA and other authorities
determine the source and cause of the event. In addition, the registration
information will enable FDA to notify quickly the facilities that might
be affected by the outbreak. The FDA expects about 420,000 facilities
to register under this requirement.
FDA also published an interim final regulation that requires the submission
to FDA of prior notice of food, including animal feed, that is imported
or offered for import into the United States. The interim final rule implements
the Public Health Security and Bio terrorism Preparedness and Response
Act of 2002, which requires that the prior notification of imported food
to begin on December 12, 2003, even in the absence of a final regulation.
This will allow FDA to know, in advance, when specific food shipments
will be arriving at U.S.port's of entry and what those shipments will
contain. This advance information will allow the FDA, working with U.S.
Customs and Border Protection (CBP), to more effectively target inspections
and ensure the safety and security of imported foods. The FDA expects
to receive about 25,000 notifications about incoming shipments each day.
Proposed rules have also been published for Maintenance of Records and
Administrative Detention of suspect foods provisions under the Act. |
Food Security: New Legislation
- Completed the IT System for Food Facility Registration and began operation
on October 16, 2003. In conjunction with FDA's Office of the Chief Information
Officer, CFSAN helped to define requirements for the system and subsequently
tested the "contractor-developed" system. CFSAN will coordinate
and post on the CFSAN Web site all documentation for the Bio terrorism Act
for industry access. CFSAN has the responsibility for processing information
into the registration system and for the System Help Desk. These projects
are being done under contracts that started in October 2003; and,
- Worked to meet the requirement of Title III, Subtitle A, Section 302
of the Public Health Security and Bio terrorism Preparedness and Response
Act of 2002 to submit an annual report to Congress describing progress
made in counter-terrorism research. FDA has completed a review of its food
security research efforts and provided a summary of its activities and accomplishments
for FY 2003. The full FDA Counter terrorism Research Report for FDA and HHS
was transmitted to Congress on October 16, 2003.
Food Security: Emergency Preparedness
- Completed training on the Food Facility Registration and Prior Notification
of Imports. The training was held on February 25 and March 12, 2003, and 48
CFSAN personnel and 52 ORA staff attended one or both sessions. On March 11
and May 13, 2003, FDA provided training to officials from all 50 states. Training
on the final Bio terrorism regulations is underway. Training for "first
responders" was held on October 15, 2003, and 178 CFSAN personnel attended.
A worldwide "Satellite downlink" public broadcast on the final regulations
for Food Facility Registration and Prior Notification of Imports was held
on October 28. The remaining training activities scheduled for November are:
(1) an orientation session for all FDA employees responsible for handling
and referring inquiries about the Bio terrorism legislation; and (2) specialized
Bio terrorism training for FDA speaker and experts;
- Participated in numerous emergency response exercises including all levels
of government, including, the TOPOFF 2 Exercise. In May,2003, FDA participated
in the TOPOFF 2 terrorism exercise, a full scale, fully functional exercise
intended to simulate two separate terrorist acts, as well as the ensuing response
for federal, state, and local governments. TOPOFF 2 was a congressionally
mandated interagency exercise on a national and international scale. Additional
exercises include:
-- Numerous internal exercises in FY 2003 - e.g., BSE and a food contamination
exercise;
--Exercises with other federal agencies - e.g., Crimson Winter with USDA
(Foot and Mouth Disease); and,
--Participation with HHS in joint exercises with USDA at the Deputy Secretary
level;
- Published a final guidance document related to food security entitled: Food
Producers, Processors, and Transporters: Food Security Preventive Measures
Guidance. This guidance is designed as an aid to operators of food establishments
(for example, firms that produce, process, store, repack, re-label, distribute,
or transport food or food ingredients). It identifies the kinds of preventive
measures that operators may take to minimize the risk that food under their
control will be subject to tampering or other malicious,criminal or terrorist
actions;
- Published a final guidance document related to food security entitled: Importers
and filers: Food Security Preventive Measure Guidance. This final guidance
is designed as an aid to operators of food importing establishments, storage
warehouses, and filers. It identifies the kinds of preventive measures that
they may take to minimize the risk that food under their control will be subject
to tampering or other malicious, criminal or terrorist action;
- Published draft Guidance for Industry titled: Cosmetics Processors and
Transporters Cosmetics Security Preventive Measures Guidance. This draft
guidance represents the Agency's current thinking on appropriate measures
that cosmetics establishments may take to minimize the risk that cosmetics
under their control will be subject to tampering or other malicious, criminal,
or terrorist actions;
- Published draft Guidance for Industry titled: Retail Food Stores and
Food Service Establishments: Food Security Preventive Measures Guidance.
This draft guidance represents the Agency's current thinking on the kinds
of measures that retail food store and food service establishment operators
may take to minimize the risk that food under their control; will be subject
to tampering or other malicious, criminal, or terrorist actions;
- Published Guidance for the Dairy Industry entitled: Dairy Farms, Bulk
Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors --Food
Security Preventive Measures Guidance on July 11, 2003. This guidance
is designed as an aid to operators of dairy farms, bulk milk transportation
operations, bulk milk transfer stations and fluid milk processing facilities.
It identifies the kinds of preventive measures operators of these establishments
may take to minimize the risk that products under their control will be subject
to tampering or other malicious, criminal, or terrorist actions;
- Completed and placed on the CFSAN intranet a laboratory security document
entitled: "Framework for Ensuring the Security of CFSAN Laboratory
Facilities: Secure Handling and Use of Select Agents in the Center for Food
Safety and Applied Nutrition". This document was developed to provide
guidance for establishing and maintaining accountability of hazardous materials,
with particular reference to "Select agents" as required under the
Bio terrorism Act of 2002; and,
- Expanded federal, state and local involvement in FDA's eLexnet system by
having 55 laboratories participate in the system. This exceeded the performance
goal.
Foods
Program Activity Data
|
FY 2003
Actual |
FY 2004
Estimate |
FY 2005
Estimate |
FOOD & COLOR ADDITIVE PETITIONS |
|
Petitions Filed |
8 |
18 |
18 |
Petitions Reviewed* |
14 |
20 |
20 |
* Number reviewed includes those approved, withdrawn,
or placed in abeyance because of deficiencies during the FY and some submissions
that were received in the previous FY. |
|
PREMARKET NOTITICATIONS FOR
FOOD CONTACT SUBSTANCES |
|
Notifications Received |
98 |
110 |
130 |
Notifications Reviewed** |
91 |
110 |
130 |
**Number reviewed includes those that became effective
or were withdrawn. |
|
INFANT FORMULA NOTIFICATIONS |
Notifications Received a |
44 |
40 |
40 |
Notifications Reviewed b |
54 |
40 |
40 |
aNumber of submissions received in current
FY include some received late in the FY.
bNumber of submissions reviewed includes some submissions that
were received in the previous FY. |
|
|
NEW DIETARY INGREDIENT NOTIFICATIONS*** |
Submissions Receiveda |
58 |
75 |
80 |
Submissions Reviewedb |
58 |
72 |
76 |
***A single notification may
address one or more new dietary ingredients. For example, FDA has received
at least 15 notifications that pertain to 2 up to16 new dietary ingredients
in a single notification.
aNumber of submissions received in current FY includes some
received late in the FY that will be completed in the next FY when the
75-day due date occurs.
bNumber of submissions reviewed in the current FY includes
some submissions that were received in the previous FY where the 75-day
due date occurred in the current FY.
|
Field Foods
PROGRAM OUTPUTS-
DOMESTIC INSPECTIONS |
FY 2003
Actual |
FY 2004
Estimate |
FY 2005
Estimate |
|
|
|
|
Domestic Food Safety Program Inspections |
7,218 |
7,000 |
7,750 |
Imported and Domestic Cheese Program Inspections |
523 |
800 |
800 |
Domestic Low Acid Canned Foods/ Acidified Foods Inspections |
623 |
600 |
600 |
Domestic Fish & Fishery Products (HACCP) Inspections |
2,561 |
3,700 |
3,700 |
Import (Imported Seafood Program Including HAACP) Inspections |
702 |
700 |
700 |
Juice HACCP Inspection Program (HACCP) |
311 |
200 |
200 |
Interstate Travel Sanitation (ITS) Inspections |
1,629 |
1,900 |
1,900 |
State Contract Food Safety ( Non HACCP) Inspections |
5,909 |
7,177 |
7,177 |
State Contract Domestic Seafood HACCP Inspections |
902 |
986 |
986 |
State Partnership Inspections |
1,579 |
2,000 |
2,000 |
Total FDA and State Contract Inspections |
21,957 |
25,063 |
25,813 |
State Contract and Grant Foods Funding |
$4,600,000 |
$9,600,000 |
$32,600,000 |
--An estimated $28 million will
be provided to the States for the Food Emergency Response Network; it
will include $23 million in new funds for FY 2005 and $5 million in recurring
funds from the FY 2004 appropriation. |
|
|
|
|
Domestic Field Exams/Tests |
9,748 |
5,385 |
5,385 |
Domestic Laboratory Samples Analyzed |
14,505 |
17,000 |
17,000 |
|
|
|
|
PROGRAM OUTPUTS-
IMPORT/FOREIGN INSPECTIONS |
FY 2003
Actual |
FY 2004
Estimate |
FY 2005
Estimate |
All Foreign Inspections |
145 |
255 |
255 |
|
|
|
|
Import Field Exams/Tests |
78,659 |
60,000 |
97,000 |
Import Laboratory Samples Analyzed |
25,736 |
31,700 |
32,000 |
|
104,395 |
91,700 |
129,000 |
In the spring of 2003, Operation Liberty Shield, a one-time multi-department,
multi-agency national plan resulted in increased protections for America's
citizens and infrastructure. By leveraging its resources with partners,
FDA increased surveillance of domestic and imported foods and enhanced collaboration
with state and other government agencies. FY 2003 Food Import Field Exams
increased due to unanticipated activities that were the result of this one-time
initiative. |
|
|
|
Import Line Entry Decisions |
5,975,567 |
7,100,000 |
8,300,000 |
Percent Physical Exams Import Entries |
1.75% |
1.29% |
1.55% |
FIELD COSMETICS
PROGRAM OUTPUTS-
DOMESTIC INSPECTIONS |
FY 2003
Actual |
FY 2004
Estimate |
FY 2005
Estimate |
|
|
|
|
All Inspections |
142 |
100 |
100 |
Domestic Field Exams/Tests |
519 |
75 |
75 |
|
|
|
|
PROGRAM OUTPUTS-
IMPORT/FOREIGN INSPECTIONS |
Import Field Exams/Tests |
2,894 |
700 |
700 |
Import Laboratory Samples Analyzed |
254 |
100 |
100 |
Import Physical Exam Subtotal |
3,148 |
800 |
800 |
|
|
|
|
Import Line Entries |
753,809 |
900,000 |
1,000,000 |
Percent Physical Exams of Import Entries |
0.42% |
0.09% |
0.08% |