|FY 2005 Actual||FY 2006 Enacted 1/||FY 2007 Estimate||Increase or Decrease|
Cost of Living
Budget Authority FTE
1/ Includes a one percent rescission
|Fiscal Year||Program Level||Budget Authority||User Fees||Program Level FTE|
Statement of the Budget Request
The Foods Program request is $449,687,000 to perform the following:
- Ensure that the food supply is safe, nutritious, wholesome, and honestly and otherwise properly labeled and that cosmetics are safe and honestly and otherwise properly labeled.
- Safeguard the U.S. public by defending the food system against terrorist attacks, major disasters, and other emergencies.
- Identify food-related health hazards.
- Support Homeland Security Presidential Directive/HSPD-9, "Defense of the United States Agriculture and Food."
- Take corrective action to reduce human exposure to food related health hazards and the possibility of food-related illnesses and injuries.
- Take timely and appropriate action on new food ingredients before they go on the market to ensure their safety.
- Continue applied research programs that provide the necessary basis for regulatory decisions for protecting public health.
- Educate and train consumers and industry on food safety and food security.
- Set standards and develop regulations for the food industry.
Conduct investigational, inspectional and laboratory functions to ensure that FDA-regulated products comply with the laws and regulations that FDA is charged with enforcing.
- Respond rapidly to emergencies, and redirecting field efforts, as necessary, to respond to unforeseen events.
- Manage and conduct criminal investigations of matters within the Agency's jurisdiction, including advising and assisting the Commissioner and other key officials on legislation and policy involving criminal justice matters.
- Monitor clinical research and conduct inspections of FDA-regulated products before they are marketed to ensure that manufactured products will be safe.
- Perform field examinations of imported products to determine whether import entries comply with FDA regulations.
The Foods Program regulates all food except meat, poultry, and liquid, frozen and dried eggs, which are regulated by the USDA. The Center for Food Safety and Applied Nutrition (CFSAN), in conjunction with ORA, promotes and protects public health by ensuring that the food supply is safe, sanitary, wholesome, and honestly and otherwise properly labeled, and that cosmetic products are safe and properly labeled. Current trends in the food industry promise better nutrition, greater economies and wider choices for the U.S. consumer than ever before. We face many challenges to ensuring food safety and food defense, including:
- The volume and diversity of imported foods has risen dramatically over the last few decades, with foods once considered exotic now found throughout the U.S.
- The global 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 plant derived foods using biotechnology, with many containing genetic characteristics that resist pests. Other foods with additional traits, such as higher nutrient content or improved flavor, are expected soon.
- The dietary supplements industry and the consumption of these products have grown dramatically.
Each of these present 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.
Scope of Responsibility
CFSAN, along with ORA, regulates $417 billion worth of domestic food, $49 billion in imported foods, and $59 billion (including $4 billion imported) in cosmetics sold across state lines. FDA's regulatory responsibility takes place from a products' point of U.S. entry or processing to its point of sale, with approximately 210,000 food establishments (or 420,000 if foreign establishments that must register with FDA to export food to the U.S. are included) and 1,500 cosmetic firms.
The Foods program's primary responsibilities include regulatory and research programs to address health risks associated with foodborne chemical and biological contamination. Activities include:
- Current good manufacturing practice compliance; seafood Hazard Analysis and Critical Control Point (HACCP), and juice HACCP regulations.
- Good agricultural practices.
- Safety of food ingredients and packaging (including ionizing radiation) and color additives.
- Safety of foods and ingredients developed through biotechnology.
- Regulations and activities dealing with the proper labeling of foods (e.g., ingredients, nutrition health claims) and cosmetics.
- Regulations and policy on the safety of dietary supplements, infant formulas, and medical foods; food industry postmarket surveillance and compliance.
- Consumer education and industry outreach; cooperative programs with state and local governments; and regulatory and research programs to address the safety of cosmetic products.
The Foods program is also responsible for development and implementation of the food defense provisions outlined in the Bioterrorism Act of 2002 (BT Act) and implementing Homeland Security Presidential Directive-9 (HSPD-9) to safeguard the food supply. Because a growing proportion of the U.S. food supply is imported, we also work with international organizations and occasionally directly with foreign governments to ensure their understanding of U.S. requirements and to harmonize international food standards.
Through risk-based domestic and foreign inspections of food establishments conducted by ORA, we are able to assess industry compliance with current Good Manufacturing Practice (cGMP) and HACCP requirements for a myriad of products. In particular, ORA inspects thousands of domestic firms identified as high-risk food establishments consisting of manufacturers and packers/repackers processing products. These products 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, ORA responds to emergencies and investigates incidents of product tampering and natural or intentional disasters that may affect FDA-regulated goods. In instances of criminal activity, the regular field force is complemented by the Office of Criminal Investigations (OCI).
During FY 2005, which was the latest performance period, the Foods program successfully achieved or exceeded 7 out of 9 targets for its FY 2005 performance goals. Of those not achieved, one target is expected to be met when data becomes available later in FY 2006. Another showed improvement over the FY 2004 actual data and narrowly missed the target because changes in one state's legislation did not take place in time to adopt the Food Code within fiscal year 2005. For more information about these performance goals and results, please see the Performance Detail section.
The American public fully expects its food--including any substances added to food--to be safe, regardless of who consumes the food, the quantity consumed, or the period of time over which it is consumed. The requirement that chemical substances used as food additives be shown to be safe before they can be introduced into the food supply is a critical link in the food safety chain. Under the FD&C Act, FDA must review and approve food and color additives for safety before food manufacturers and distributors may market them. To initiate this review, sponsors are required to submit a petition that includes appropriate test data to demonstrate the safety of the substance for its intended use. Performance is defined in terms of a review of all parts of a petition within 360 days of receipt. In addition, the FDA Modernization Act (FDAMA) established a notification program for food additives that are food contact substances (e.g., packaging materials). Under the provisions of this notification, a food contact substance may be marketed 120 days after notification unless the agency objects. As part of the FY 2007 strategic redeployment of resources to fund higher priority FDA programs (e.g., food defense and pandemic influenza), this program will be discontinued. The Agency also has a notification program for substances that are Generally Regarded as Safe (GRAS). In addition, the Agency consults with developers of foods derived from bioengineered plants to ensure that any safety and regulatory questions are resolved prior to marketing. Finally, the Agency reviews notifications for dietary supplements containing "new ingredients" within 75 days as well as infant formula notifications within 90 days. CFSAN's key challenge in the premarket area is to expeditiously review new food products without jeopardizing public safety.
|FY 2004 Results||Context|
|Complete review and action on the safety evaluation of 50% of direct and indirect food and color additive petitions which includes petitions for food contact substances within 360 days of receipt.||FDA has met the targets for this performance goal consistently since FY 1999.||This goal refers to completion of the safety evaluation of food and color additive petitions which includes those for food contact substances. This includes a review of the information in a filed petition, and one of two conclusions reached: either the petition does not support the requested action and a letter to that effect is transmitted to the petitioner with an explanation of why we reached the conclusion; or based on the review, we are prepared to recommend to the agency officials authorized to sign an order, that the use of the additive be approved (or denied), and communication of this information to the petitioner.|
Statement of Budget Request
This request for Budget Authority supports various activities that contribute to the accomplishment of program outputs and performance goals, and presents FDA's justification of base resources and selected FY 2005 accomplishments by strategic goal.
Program Resource Changes
Pandemic Preparedness: +$8,348,000 and 15 FTE
The National Strategy for Pandemic Influenza, issued by President Bush November 1, 2005, guides our nation's preparedness and response to an influenza pandemic, with the intent of (1) stopping, slowing or otherwise limiting the spread of a pandemic to the United States; (2) limiting the domestic spread of a pandemic, and mitigating disease, suffering and death; and (3) sustaining infrastructure and mitigating impact to the economy and the functioning of society. The Strategy charges the U.S. Department of Health & Human Services with leading the federal pandemic preparedness.
FDA will focus resources on those foods that require surveillance and testing to ensure that the virus is not present or, if present, to ensure that the food can be properly treated to ensure safety. Specifically, FDA will:
- Develop/validate detection methods in foods of concern (shell eggs, soups containing poultry, bird game meats).
- Conduct inactivation/intervention studies of bird flu virus during processing of foods of concern.
- Coordinate with USDA on sampling and testing poultry products at import inspection stations and poultry processing plants for traces of antiviral residues.
- Issue Custom Alerts to prevent the illegal importation of antivirals into the U.S.
- Develop, integrate and execute FDA animal and food response plans and quarantine activities, in coordination with USDA and CDC.
- Equip field labs and support technology transfer and training of field scientists to ensure adequate capacity to respond to outbreaks of avian influenza.
- Improve FDA's capacity to conduct domestic and import surveillance and respond to reports of food or foodborne illness associated with viruses.
- Support national pandemic influenza surveillance integration efforts with a comprehensive system to detect highly pathogenic strains of avian influenza.
- Provide technical assistance to industry and conduct public education on the potential risks of foodborne avian influenza and measures to prevent illness.
Food Defense: + $18,388,000 and 4 FTE
FDA's food defense program supports Homeland Security Presidential Directive (HSPD-9) on safeguarding the American Public by defending America's food supply against terrorist attacks post-September 11, 2001. HSPD-9 lays out a framework for augmenting the nation's food safety protections and establishing a partnership among the various organizations responsible for protecting the nation's food supply.
CFSAN will use the additional funds to continue lab preparedness efforts and for necessary short term research projects. Many of the projects undertaken are derived from direct interaction with industry following vulnerability assessments. The results of these projects can be communicated directly to industry. These efforts will result in a better understanding of which interventions work, and which do not, for certain agents in specific foods.
Further joint food defense and food safety assignments will enhance and facilitate the integration of food defense with food safety. In these assignments, samples that are obtained as part of routine food safety programs will also be tested in a variety of labs for a range of select agents that are of most concern. The foods chosen for these assignments are generally ones that we have most concern about based on vulnerability assessments.
The Field will use the additional resources for the following activities.
- Expand the FERN system to include 16 State laboratories, provide grants and technical support to these laboratories and build analytic surge capacity to respond to a terrorist attack.
- Manage, through the National Program Office, FERN's ability to respond for a terrorist attack on (or threat to) the food supply or other food-related emergency by creating capability in FERN laboratories through training and proficiency testing.
- Continue Field support for food defense operations, including targeting potentially high-risk imported foods through Prior Notice Import Security Reviews based on intelligence, FDA inspection reports, discrepancies in prior notice reporting and sample collection and analysis.
Cost of Living +$6,877,000
FDA's request for inflationary pay costs is essential to accomplishing our public health mission. Payroll costs account for more than sixty-percent of the FDA budget, and the Agency is not able to absorb this level of inflation on such a significant portion of its resources. The increase will allow FDA to maintain staffing levels, including a national cadre of specially trained scientific staff. The total estimate for pay increases is $20,267,000. The Foods portion of this increase is $6,877,000. These resources are vitally important for FDA 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.
Foods Reductions -$22,647,000 and -105 FTE
To fund FY 2007 priority initiatives such as such as food defense and pandemic influenza, FDA re-deployed resources from base programs. To accomplish this strategic redeployment and fund new, high priority initiatives, CFSAN reductions include: Research, Cosmetics, Dietary Supplements, Proficiency Testing, Outreach and Standard Setting, Regulatory Support, Premarket Food and Color Additives, and Food Contact Substances Notification. The Field - Foods reductions include lower levels of effort in these activities: analysis of low-risk domestic and import samples (FDA will continue to analyze high risk samples, including those flagged by the Prior Notice Center), research related to laboratory analytical methods, compliance and recall functions and management, supervisory, and coordination personnel at multiple locations.
Proposed Fees (Reclassified as Mandatory - Non-Add)
Reinspection User Fee (Mandatory): $5,215,000 and 44 FTE (Non-Add)
The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements. Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $22.0 million in revenue, an amount sufficient to fully fund reinspections. The Foods program component of this user fee is $5,215,000 and 44 FTE.
Food and Animal Feed Export Certification User Fee: $3,473,000 and 23 FTE (Non-Add)
The Administration is proposing legislation authorizing FDA to collect user fees for issuing food and animal feed export certificates. Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $3.5 million in revenue, an amount sufficient to fully fund the export certificate program. Private sector exporters would bear the cost of the program, but would reap its benefits through the Agency's enhanced ability to facilitate exports of their products. The Foods program component of this user fee is $3,473,000 and 23 FTE.
Justification of Base
FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products
The single most important factor in ensuring that citizens lead long, healthy lives and minimize the likelihood of chronic disease is the availability and effective use of science-based nutrition information. This will help consumers make wise choices about the foods they consume. This year the agency published two final regulations that will provide consumers with better label information and foster the development of healthier food products for American consumers. First, the trans fat labeling rule requires the amount of trans fat to be declared on the Nutrition Facts panel directly below the saturated fat line. The level of trans fatty acids in the diet affects risk of coronary heart disease. This rule was published in 2003 and became effective January 1, 2006 for all food under FDA jurisdiction. FDA estimates that 3 years after the January 1, 2006 effective date, trans fat labeling can lead to the prevention of 600 to 1,200 cases of coronary heart disease and 240-480 deaths each year, saving $900 million to $1.8 billion per year in medical costs, lost productivity, and pain and suffering.
Second, the term "healthy" is a very strong nutrient content claim. It specifies strict nutrient levels for fat, saturated fat, cholesterol, sodium and beneficial nutrients. The "healthy" final rule modifies the sodium levels in foods permitted to bear the term "healthy". Such foods include individual foods, meal products like burrito meals, and main dish products like chicken pot pie. These sodium limits are lower than for similar conventional foods, but not so low that manufacturers would be discouraged from developing and marketing products that have healthy levels of a variety of nutrients.
Research Development and Evaluation Activities
CFSAN's research, development, and evaluation activities are an integral part of the programs needed to achieve this strategic goal. Activities under this goal include ensuring food safety and food defense, and enhancing the ability for consumers to make sound nutrition choices. This research is necessary to ensure the health and well being of the American public and to identify and eliminate foodborne hazards, both naturally occurring and intentionally introduced into the food chain. The research is typically not conducted by industry or other research agencies. It provides the basis for nutrition labeling regulations and guidance, identification of foodborne pathogens, toxins and select agents, and the development of mitigation and prevention strategies. The research provides the scientific basis for regulating the food-producing and processing industries to ensure a safe and nutritious food supply from farm-to-table. Applied research activities include efforts to:
- Develop, with available resources, analytical methods for measuring specific nutrients or dietary ingredients that are potential safety concerns (e.g., toxic or carcinogenic components of botanicals).
- Develop analytical methods for measuring food components that are the subject of proposed regulations (e.g., soy isoflavones and trans fatty acids) to establish and maintain the credibility of information on the food label.
- Evaluate and/or validate test kits for food allergen contamination. This is necessary in order to systematically assess key characteristics of proteins (e.g., thermal stability, acid digestion resistance) that may be associated with potential food allergenicity and to establish and maintain the credibility of information on the food label.
- Continue, at a reduced level, research on botanical ingredients in dietary supplements (acquisition, validation, and characterization of authentic botanical reference materials), as part of the 10-year Dietary Supplement Strategic Plan. This will be done through a cooperative agreement between FDA and the University of Mississippi's National Center for Natural Products Research.
- Conduct research in support of the 2010 Dietary Guidelines for Americans, such as:
- Developing a scientifically valid definition for "nutrient density" for use on the food label and determining what criteria are necessary for foods to meet this definition.
- Conducting studies to determine the barriers to complying with the guidelines for children, low-income populations, and various ethnic groups to change their eating behaviors and identifying various mechanisms to motivate individuals to change.
- Developing and testing both individual-based and population-based interventions designed to implement the guidelines
- Conducting consumer research to evaluate food safety messages and corresponding changes in behavior.
- Continue the development of a Food Source Identification and Tracking System. This is a stand-alone computer modeling tool for projecting the probabilities and distribution of human morbidity/mortality outcomes and economic effect, associated with foodborne hazards. It is intended to aid in developing strategies to respond quickly and efficiently to crises and emergencies involving the food supply.
- Develop enhanced sampling and detection methods for surveillance for priority chemical, microbiological, and radiological agents in vulnerable foods, including field deployable and in-line sensor-based screening, analytical, and investigational (forensic) technologies;
- Develop multiple-analyte surveillance methods that allow the simultaneous, real-time evaluation of foods for several hundred toxic chemicals of food safety and/or food defense concern.
- Develop bioinformatic techniques that provide enhanced use of genomic, proteomic, and metabolomic information to allow more effective food safety, food defense, and nutrition regulatory decisions by considering the diversity of humans, foods, and food processing technologies.
- Calories Count: Continue, through CFSAN's Obesity Working Group (OWG), to confront the obesity epidemic in the U.S. and help consumers lead healthier lives through better nutrition by outlining and implementing an action plan to combat obesity.
- Labeling/Health Claims: Continue to develop better information for consumers about the health consequences of their diet. Also, continue to devote resources to finalize and implement programs focusing on the guidance and procedures for qualified health claims in the labeling of conventional human food and human dietary supplements.
- Keystone Dialogue: Draft a final report for FDA review. In June 2004, FDA contracted with the Keystone Center to convene a national forum/dialogue with stakeholders, including public and private decision makers, to explore and work toward agreement on concrete steps that can be taken to address obesity in the context of away-from-home foods. FDA is represented on Keystone's planning group for the dialogue sessions and these completed sessions are the basis for the final report.
- Food Code: The Food Code model assists food control jurisdictions at all levels of government. The model provides them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. FDA will continue to update the Food Code. FDA will also increase risk management strategies and communication to government, industry and consumers for ensuring the safety of the nation's food supply. This will be accomplished by quantifying actual performance of the percentage of the total US population that will live in States that have adopted the Food Code. The Food Code is a component of an even larger effort aimed at decreasing foodborne illness, the National Retail Food Regulatory Program Standards program. Through this program, FDA will continue to:
- Assist state programs and provide oversight in implementing the standards program.
- Continue to provide support and guidance to jurisdictions already enrolled.
- continue support of conducting audits of those enrolled in the standards program.
- Surveillance Systems: CFSAN will continue to evaluate the CDC foodborne disease outbreak surveillance system data to identify and analyze outbreaks associated with FDA-regulated products. Areas of focus will include the number of outbreaks, cause agents, morbidity and mortality, seasonality, geographic location, site of food preparation, contributing factors and whether the product is domestic or imported. CFSAN will also help 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.
Food Safety for Moms-to-Be
FDA launched a new comprehensive food safety education program focusing on prevention of foodborne illness for pregnant women. Six million American women become pregnant each year and 10,000 give birth each day. This program highlights foodborne illness risks that pregnant women and their fetuses are particularly vulnerable to, such as Listeria monocytogenes, methylmercury, and the Toxoplasma parasite. FDA created an educator's toolkit, including a fact-filled Educator's Resource Guide and an award-winning video featuring the Discovery Channel's Dr. Andrea Pennington, for healthcare professionals to use when talking with women about pregnancy and foodborne illness. The agency produced and distributed about 60,000 free kits to organizations such as the American College of Nurse Midwives, American Academy of Medicinal Administration, Association of Women's Health, Obstetric, and Neonatal Nurses, National Women's, Infants', and Children's Association, USDA Cooperative Extension Service locations, and many others. FDA continues to offer kits in two languages, English and Spanish, upon request. FDA is also promoting a website (http://www.cfsan.fda.gov/pregnancy.html) to women and healthcare professionals, so they can get information directly.
- FoodNet/PulseNet: CFSAN will continue to participate in national surveillance and emergency response programs, such as the Foodborne Disease Active Surveillance Network (FoodNet) and PulseNet. FoodNet, a collaborative project with the CDC and USDA, conducts active surveillance for foodborne diseases and related epidemiology studies; PulseNet is a national network of public health laboratories that performs DNA "fingerprinting" on bacteria that may be foodborne.
FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health
Research Development and Evaluation Activities
The Foods program's research, development, and evaluation activities support this strategic goal with work performed in food safety and defense, food nutrition, and cosmetic product safety. The effective and timely evaluation and subsequent scientific review of new technologies for enhanced food and cosmetic safety, as well as innovative products for enhanced nutritional well-being, are critical for the United States to maintain its leadership role in the increasingly global trade of food. This research provides the scientific basis for identifying and recommending the adoption of innovative technologies that reduce public health concerns related to foodborne pathogens, toxins, and select agents. The research provides the scientific basis for regulating the food producing and processing industries to ensure a safe and nutritious food supply from farm-to-table. With available funding, the foods program will:
- Develop risk assessments, risk assessment techniques, and critical scientific data needed to ensure that international food safety standards developed through intergovernmental organizations are based on sound science.
- Develop innovative "in shell" pasteurization techniques that lead to the development of new egg products that eliminate the risk of egg-associated Salmonella Enteritidis infections.
- Premarket Program: The American public fully expects its food --including any substances added to food--to be safe, regardless of who consumes the food, the quantity consumed, or the period of time over which it is consumed. The requirement that chemical substances used as food additives be shown to be safe before they can be introduced into the food supply is a critical link in the food safety chain. Base resources will continue to be devoted to the following premarket activities.
- Continue, at a reduced capacity, to review the safety of food and color additives before they are marketed by food manufacturers and distributors.
- Continue the review of notifications for substances that are Generally Regarded as Safe (GRAS).
- Provide, through the Food Additives Regulatory Management (FARM) system, information management tools for food additive petition reviewers. These tools will maximize productivity and expedite the petition review process and subsequent safety decisions. This system also helps FDA perform associated activities such as responding to and managing FOIA requests and correspondence. All paper and electronic documents are converted to standard formats and stored in an electronic document management system. Each reviewer is able to retrieve documents at their desks using a combination of attribute and full-text search capabilities supported by a thesaurus maintaining nomenclature control.
- Bioengineered Foods: Continue to consult with developers of foods derived from bioengineered plants to ensure that any safety and regulatory questions are resolved prior to marketing. Activities involve labeling, consultations with industry and the issuance of guidance to developers of these foods.
FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight
Research Development and Evaluation Activities
CFSAN's research, development, and evaluation activities in food defense and safety, food nutrition, and the safety of cosmetic products support the strategic goal. The food defense research priorities are based on determining the food/agent combinations of highest concern. Mission critical knowledge gaps are filled by translational research focused on anticipating, preventing, detecting, responding to, and recovering from terrorist assaults on the food supply. Food defense and safety research provides the basis for identifying and countering foodborne pathogens, toxins, and select agents. The research also provides the scientific basis for regulating the food producing and processing industries to ensure a safe and nutritious food supply from farm-to-table. CFSAN's food safety and food defense research approach is threefold, involving an intramural program, an extramural program, and consortia with industry and/or academia.
- Food Safety Research - the program will use available funds for:
- Delineating microbial pathogen risks associated with foods by: examining emergence in the food supply, adaptation to the barriers that are traditionally used to keep food safe, and rapid detection; characterizing the survival, growth, and inactivation of the pathogens.
- "Fingerprinting" pathogens in food; studying unique intervention technologies to prevent contamination; and arraying all this information, using risk assessment techniques, to inform risk managers. This research is the critical underpinning of regulatory policy.
- Conducting studies of how heat, ultraviolet light, irradiation, and high pressure processing can improve the safety of cheese, sprouts, juice, and eggs. These studies provide industry with information on how these technologies may be used to prevent pathogen contamination and allow FDA to develop scientifically sound guidance for small businesses.
- Enhancing foodborne virus (including avian flu) research, surveillance and response capability, and programs covering shell eggs, seafood, game meats, and other potentially at-risk foods.
- Providing the scientific tools to identify foodborne viruses in foods and technologies to remove or reduce their public health impact.
- Conducting outreach and education to inform industry and consumers of potential risks and steps to prevent virus contamination, and, as part of FDA's food safety surveys, assessing the success of consumer understanding of these risks.
- Conducting studies to provide criteria for prevention, reduction, or elimination of safety hazards affecting seafoods within the unique HACCP requirements regulating this program and/or the cooperative National Shellfish Sanitation Program with industry.
- Food Defense Research Program activities include:
- Determining the behavior of microbiological, chemical, radiological, and biologically-derived toxic agents in priority vulnerable foods during the stages of production, distribution, marketing, and preparation to develop more effective intervention technologies and conduct better vulnerability assessments.
- Enhancing information on the susceptibility of the population to microbiological, chemical, radiological, and biologically-derived toxic agents in priority vulnerable foods to identify "at risk" populations and conduct better vulnerability assessments.
- Identifying, developing, and validating new techniques for "shielding" priority vulnerable foods and their application to the development of new prevention and/or security technologies.
- Developing effective methods for ensuring that critical food production and manufacturing infrastructure can be rapidly and effectively decontaminated in event of a terrorist attack;
- Communicating foods defense research deliverables to Federal, state, and local entities and with industry, as appropriate, to further protect the food supply from deliberate attack.
- Cosmetic Safety and Color Certification Research Program activities will include, to a limited extent:
- Acquiring scientific information and developing analytical procedures to support regulatory policy and actions for cosmetic products, including methods development for contaminants, the development of methods for measuring skin absorption and metabolism, and investigating the photoactivity of cosmetics and colors.
- Developing new methods for improving the efficiency of sample analysis and confirmatory analysis in color additive certification and on the synthesis of standards used in these analytical procedures.
Base resources will help strengthen FDA's capability to identify, prepare for, and respond to potential terrorist threats and incidents. Base funds will support to following efforts:
- Continue the evaluation of the public health consequences (risk) of product-agent-activity combinations associated with tampering and/or terrorist activity.
- Continue to identify and document the types of preventative measures that companies can take to minimize the risk that food or cosmetics under their control. Resources will also enable CFSAN to continue to work with industry to ensure that the appropriate preventative measures are implemented.
- Continue efforts to develop and validate new methods for use in surveillance and monitoring of potential threats. 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 to permit continuous monitoring of foods both during production and at import entry sites.
- Continue efforts to improve the safety of food through 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.
- Continue work involving Agent Characteristics. Essential to improving FDA's ability to detect, quantify and control foodborne pathogens, toxins and chemicals that threaten the food supply is performing additional assessments. These are 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.
- Continue Dose Response Relationships/ Threat Assessments. Essential to accurately estimate the threat posed by such exposures is an understanding of the dosage amounts needed to inflict human disease or produce adverse reactions, where exposure occurs through consumption of different food matrices.. 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.
- Continue the development of scientific methods to support the critical infrastructure. This includes:
- Articulation of interim methods.
- Development and delivery of training modules.
- Establishment and integration of laboratory communication systems and protocols.
- Integration with agency crisis management procedures.
- Establishment of methods validation systems.
- Enhancement of the preparedness of CFSAN laboratories that are part of FERN and/or CDC's Laboratory Response Network.
- Continue the laboratory accreditation program. This program covers all center foods facilities for harmonizing practices in food laboratories. The program better ensures acceptance of FDA laboratory results throughout the world (this will include enhanced data quality systems and support for instrument validation).
- Continue diagnostic tests to produce tools needed for field and import examinations to determine if a product has been tampered with or tainted.
- Maintain the number and capabilities of state health and agriculture laboratories, and current laboratories connected to the electronic Laboratory Exchange Network (eLEXNET). Doing so allows the labs to exchange data on select biological agents (possibly including anthrax, botulinum toxin, brucellosis and other potential infectious diseases) and food pathogens. This is the first Internet-based food safety system that will link state and local organizations with Federal partners to respond more quickly to outbreaks.
- Maintain preventative standards, education campaigns and research to improve food safety and security through rapid tests of detection.
- Continue streamlining techniques to rapidly detect and assess bacterial strains of bioterrorist agents (pathogens/chemicals).
- Continue to assist in developing irradiation techniques and methods to kill anthrax spores in the mail by coordinating efforts with industry, which already uses irradiation to sanitize poultry, ground beef, spices, and medical equipment.
- CFSAN will enhance coordination of food defense and counter-terrorism issues with Federal, state, and local governments and other organizations through full participation in the White House Interagency Food Working Group and sub-groups.
FDA built its food security programs on the foundation of food safety infrastructure and developed processes to assess the vulnerability of different categories of food. Through these risk assessments, FDA has ranked the most serious risks of intentional food contamination during its production and distribution. Since September 11, 2001, FDA has conducted many vulnerability assessments for those food products under our regulatory jurisdiction. The agency carried out its own initial analysis of the likelihood of an attack on the food supply taking place, and the severity of its public health impact. The agency's findings were subsequently validated by two respected scientific institutions -- the Institute of Food Technologists and the Battelle Memorial Institute.
FDA continues to refine the tools used to conduct vulnerability assessments – Operational Risk Management (ORM) and CARVER + Shock. Working in partnership with the food industry, vulnerability assessments have been completed for bottled water, fluid dairy products, juice products, and infant formulas. Evaluations involving other foods are in process. Results of these assessments will be used to develop technology interventions and countermeasures, identify research needs, and provide more guidance to the private sector. Industry uses the results of these assessments to better protect their food production processes and products from intentional contamination.
FDA has joined with FBI, USDA and DHS to engage industry and states in conducting these assessments through the Strategic Partnership Program-Agroterrorism (SPPA). This effort focuses on enhancing local law enforcement and food safety officials' lines of communication and improving preparedness and response capabilities based on knowledge of food production vulnerabilities. To date, under the SPAA, FDA has completed two assessments - 1) a yogurt production assessment in Minnesota and 2) a grain export elevator assessment in Louisiana. Assessments are planned for New Jersey, New Hampshire, Florida, Nebraska, Iowa and California in 2006.
Food Defense - Field Activities
- Continue to implement regulations under the Bioterrorism (BT) Act, such as detaining suspect food when the agency has credible evidence or information that it presents a threat to humans or animals.
- Strengthen relationships with State partners through the FERN, a national laboratory network that enables FDA to test thousands of food samples within a matter of days if there is a food terrorism event, or a foodborne illness outbreak.
- Fund FERN state Cooperative Agreements for increased laboratory surge capacity and the National Surveillance Sampling Program to build the capacity to effectively monitor the food supply.
- Conduct training and proficiency testing of FERN laboratories to assure that these laboratories can achieve consistent testing results.
- Expand the use of eLEXNET which collects lab analytical data on chemical, microbiological, and other contaminants and links federal, state, and other laboratories. This data capture and exchange system provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods and enables health officials to assess risks and analyze trends.
- Develop effective prevention strategies to "shield" the food supply from terrorist threats, including the capacity for rapid, coordinated responses to a food borne terrorist attack.
- Intensify the review of products offered for import into the U.S. for safety and security issues.
- Expand field laboratory and contract activities to evaluate and develop existing and potential laboratory and field test kits for product contaminants.
- Provide training, equipment, facilities, and information technology support to field staff to work on counter terrorism initiatives with a focus on imports.
- FDA Unified Registration and Listing System (FURLS): FURLS supports the requirements of the BT Act of 2002 as it relates to Food Facility Registration, Drug Facility Registration and Listing, and Prior Notice of Food Shipments into the U. S. FDA began this effort by identifying opportunities for unification between the FDA Drug Facility Registration and Listing requirements with those of the Food Facility Registration Requirements.
- Continue to develop the Food Registration and Prior Notice systems that became operational in the first quarter of FY 2004.
- Collaborate with Customs and Border Patrol. This will include:
- Monitoring the importation of regulated products and follow-up on the status of products refused entry.
- Evaluating the accuracy of information import filers provide to the FDA automated entry review system regarding regulated products offered for entry into domestic commerce.
- Continuing to conduct food import exams of food products offered for import into the country.
- Expand import surveillance at international mail facilities and courier hubs.
- Bovine Spongiform Encephalopathy (BSE): BSE is a deadly chronic, degenerative disorder affecting the central nervous system. BSE and Chronic Wasting Disease (CWD) both belong to a group of fatal progressive degenerative neurological diseases, including those that affect humans such as Creutzfeldt-Jakob disease (CJD). Regulated products 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, at a reduced level of effort, 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.
- Continue to conduct research on decontamination or deactivation procedures.
- Natural Disaster Food Safety Response: Natural disasters, such as Hurricane Katrina, pose many food safety related issues. FDA plays a critical role in food safety response and recovery efforts. Base funding will enable FDA to continue to:
- Provide assistance to state and local governments to address food safety issues.
- Provide information to consumers to aid in evaluation of stored food and water they have in their homes in light of power outages and contaminated water supplies.
- Continue to ensure food imported and/or donated food from other countries as part of relief efforts is safe and does not pose unreasonable risks to human safety.
- Provide assistance in decontamination efforts for food processing and food service facilities during clean up and recovery.
- Provide assistance in adapting good agricultural practices for foods grown in disaster areas.
- Chemical Contaminants, Pesticides and other Hazards
- Pesticides Monitoring: Continue, at a reduced level, to collect and analyze food samples for pesticide residues not only to ensure that the U.S. food supply is safe, but also to reduce dietary exposure.
- FDA's Dioxin Strategy: FDA will continue, at a reduced level, implementation of its dioxin strategy including monitoring, methods development, and identification of opportunities to reduce exposure.
- Perchlorate Analytical Method: FDA developed an accurate and sensitive method to determine the level of perchlorate in selected fruits and vegetables and also in bottled water and milk using ion chromatography-tandem mass spectrometry. FDA will continue, at a reduced level, to use of this method for the detection of perchlorate.
- International Codex-Related Activities: Continue, at a reduced level, its public health involvement in the work of the Codex Alimentarius Commission (Codex). FDA's scientific expertise has been crucial to the development of critical scientifically sound international food safety standards that are used by countries importing food into the United States, by US companies exporting to other countries, and are also used by the World Trade Organization to resolve trade disputes.
- Food CGMP Modernization: Complete the Agency's review of the draft report on Current Good Manufacturing Practices (CGMP) modernization and develop a proposed rulemaking in relation to food CGMP modernization. FDA last revised the CGMP regulation for food in 1986. Since 1986, there has been a significant change in both the food industry and in our understanding of foodborne disease. Among the many changes that have taken place, ready-to-eat foods and fresh produce constitute a larger share of the American diet than was the case 18 years ago. These foods are commonly consumed without further cooking by the consumer and have been implicated in foodborne disease outbreaks.
- Listeria and Methylmercury: Continue to provide education and outreach activities to target audiences in the effort to train health educators to teach food safety to pregnant women and women who may become pregnant about the risks of methylmercury in seafood and Listeria monocytogenes in refrigerated food.
- Seafood Safety: Continue to work to encourage the post-harvest treatment of Gulf Coast oysters and to monitor progress toward the ISSC illness reduction goals. FDA will not be able to continue to provide funds to the ISSC to promote educational and research activities related to shellfish safety.
- Seafood and Juice Hazard Analysis and Critical Control Points (HACCP) Programs: Continue to evaluate the programs' performance, with an emphasis on identifying factors that inhibit improvements in compliance rates, in order to assess whether the program is accomplishing its objectives and to identify where and how the program needs to be re-directed. The HACCP system focuses on identifying and preventing hazards that could cause food borne illnesses rather than relying on spot-checks of manufacturing processes of finished products to ensure safety.
- Produce Safety: Foodborne illness outbreaks attributed to fresh produce have increased in the last ten years. There are a number of possible explanations, including (1) an increase in the consumption of fresh produce, (2) improved detection of outbreaks and increased awareness of fresh produce as a vehicle for foodborne illness, (3) increased complexity and reach of distribution systems, and (4) increased numbers of consumers at high risk of foodborne disease (e.g., the elderly and persons with compromised immune systems). FDA will continue to devote base resources to its produce safety programs in order to contribute to the reduction in the number of illnesses associated with these products.
CDC estimates that there are approximately 118,000 illnesses per year caused by consumption of Salmonella Enteritidis (SE) in contaminated eggs. These illnesses can be very serious, especially to the very young, the elderly, and persons with weakened immune systems. If an individual eats an egg that is contaminated with SE and that has not been fully cooked, he or she may suffer mild to severe gastrointestinal illness, short term or chronic arthritis, or death.
Working with state egg quality assurance officials, industry and consumer groups, FDA has published a proposed rule to require egg safety measures to prevent the contamination of shell eggs with SE during egg production. FDA expects to publish a final rule in 2006. Implementation of the provisions in the final rule will reduce SE prevalence in eggs.
It is estimated that implementation of the final rule will reduce the number of SE illnesses by 33,500 and be a major factor in realizing the public health goals of a 50% reduction in all salmonella illnesses and a 50% reduction in SE outbreaks by 2010. FDA will continue to devote base resources to its egg safety program in order to contribute to the reduction in the number of these illnesses.
- Dietary Supplements: The dietary supplement industry is one of the world's fastest growing with over 1,500 establishments claiming to manufacture dietary supplements and sales of $17 billion in 2000. Between 1994 and 2000, consumer spending on dietary supplements nearly doubled, with over 158 million consumers, and sales growing more than 10 percent per year. Nearly 20 million consumers use dietary supplements in conjunction with prescription products. Although this rapid growth in a time of constrained resources represent a significant challenge, FDA has published a dietary supplement strategy that sets clear program goals.
- CGMPs: Continue towards finalization of this activity. The Dietary Supplement Health and Education Act (DSHEA) provided FDA with express statutory authority to prescribe CGMP requirements for dietary supplements. On March 13, 2003, FDA published proposed CGMPs for manufacturing, packing, labeling or holding dietary supplements. The proposed CGMP requirements are intended to ensure that manufacturing practices will prevent the production of adulterated dietary supplements. The proposed CGMP rule includes provisions on the manufacturing, packaging, labeling, testing, quality control, releasing for distribution and holding of dietary supplements. Public comments have been reviewed and a draft final rule has been drafted and is currently being reviewed by OMB for clearance.
- Ephedra: Dietary supplements containing ephedrine alkaloids are adulterated because they present an unreasonable risk of illness or injury and may not be sold in the U.S. Base resources will continue to be devoted to:
- Taking strong enforcement action against continuing efforts to illegally sell these products in the U.S. or illegally export existing stock.
- Evaluating safety concerns related to dietary supplements containing other sympathomimetics, such as Citrus aurantium.
- Working with FTC, DEA, and other partners to protect the American public.
- New Dietary Ingredients: Continue to respond to premarket notifications for new dietary ingredients within the statutory time frame of 75 days.
- Food Allergens: Continue to provide more information on food labels so that allergic consumers can make safe food choices. On August 2, 2004, President Bush signed into law the "Food Allergen Labeling and Consumer Protection Act" (Public Law 108-282). The law is consistent with FDA's initiatives to empower consumers to make healthy dietary choices. It is also consistent with the Healthy People 2010 goal of reducing the number of deaths due to anaphylaxis caused by food allergens. FALCPA amends the Federal Food, Drug, and Cosmetic Act to require that the eight "major food allergens" be declared on the labels of food products labeled on or after January 1, 2006. The eight major allergens identified by FALCPA are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. These foods account for 90% of food allergic reactions.
- Cosmetics: Continue to devote base resources, at a significantly reduced level, to ensure the safety of cosmetics. The FD&C Act prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Violations of the Act involving product composition--whether they result from ingredients, contaminants, processing, packaging, or shipping and handling--cause cosmetics to be adulterated and subject to regulatory action.
Foods Field Activities
Import Entry Evaluations, Investigations, and Laboratory Analyses
Since the emergence of the "global marketplace" imported foods have grown increasingly important to the U.S. food supply. At the current rate of increase, FDA estimates that by FY 2007 the number of imported food lines will have nearly quadrupled since 1999. This rapid growth combined with the security concerns raised by terrorism and counterfeiting incidents has increased the need to electronically and physically assess the status of imported products. FDA electronically screens imports through OASIS, which is an automated system for processing and making admissibility determinations for FDA regulated products that are offered for import. Filers transmit information electronically which is then checked against automated screening criteria set by the Division of Import Operations & Policy. These criteria assign either "FDA Review" or "May Proceed" status to an entry. If a product is assigned FDA review status, then a field exam, which is a physical examination of the product to determine whether the product is in compliance with FDA requirements, may be performed. FDA's electronic screening of imports will be enhanced by the completion of the Mission Accomplishment and Regulatory Compliance System (MARCS). Field activities include the following efforts.
- Review more than 19 million import lines for admissibility into domestic commerce by the end of FY 2007.
- Focus analysis of OASIS import line data to expand use of information on manufacturer, supplier, source country, and past violations to make enhanced admissibility decisions.
- Continue to perform laboratory analysis on products offered for import into the United States.
- Continue to conduct inspections of foreign establishments as part of the Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Devices and Radiological Health programs.
- Perform periodic filer evaluations in which the import data submitted electronically to OASIS is compared against the paper documents accompanying the imported product to ensure that the data being provided to FDA is accurate.
Domestic Inspections and Laboratory Analyses
Inspections and surveillance are the primary means of assuring the safety of marketed products. Consumers rely on the FDA to prevent dangerous and unreliable products from entering commerce. Field efforts include the following activities:
- Identify the food source and contaminant of food borne illness outbreaks ranging from chemical and microbiological to physical hazards.
- Develop laboratory analytical methods to permit the analyses of products for chemical and microbiological hazards.
- Continue to analyze food samples for pesticides and environmental contaminants at a reduced rate.
FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century
CFSAN Adverse Events Reporting System (CAERS)
Prior to June 2003, several systems existed to monitor adverse events: the Adverse Reaction Monitoring System for food and color additives, the Cosmetics Adverse Reaction Monitoring Database for cosmetic products and the Special Nutritional Adverse Event Monitoring System (SN/AEMS) for dietary supplements, infant formulas, and medical foods. These systems are now combined into the CAERS database, with which CFSAN staff now track, evaluate, and monitor adverse events and consumer complaints received about regulated food products. CFSAN will continue these activities, but at a reduced rate in FY 2007. CAERS is a useful tool for identifying new and emerging food and cosmetic public health problems.
Besides mining food and cosmetic adverse event data for patterns, trends and signals, CAERS provides a database search engine capable of responding to a large variety of stakeholder inquiries, and is capable of generating yearly reports that describe the voluntary food and cosmetic adverse event reports received from consumers.
Selected FY 2005 Accomplishments
FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products
Bioterrorism Rule Outreach
- Conducted nine domestic meetings to discuss the final Recordkeeping regulation implementing Section 306 (Maintenance and inspection of Records) of the Bioterrorism Act of 2002. The final rule was published in the Federal Register on December 9, 2004. The purpose of these meetings was to provide information on the rule to the public and to provide the public an opportunity to ask questions of clarification.
Egg Safety - In-lid Labeling
- Published in the Federal Register a proposed rule entitled: "Food Labeling: Safe Handling Statements: Labeling of Shell Eggs." This notice proposes to amend the Agency's food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement "Keep Refrigerated" appears on the principal display panel or information panel.
2005 Food Code
- Completed the 2005 FDA Retail 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 (restaurants and grocery stores and institutions such as nursing homes). 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.
Safe Handling of Produce
- Launched a consumer education campaign on the safe handling of produce. A new brochure has been completed and circulated to specific risk groups as well a general distribution.
Listeria Education Program
- Carried out a multicultural food safety initiative educational program for pregnant women through Hispanic media and community-based public health specialists in high density Spanish-speaking areas on the risk of Listeria monocytogenes in cheese.
Establish FDA's Obesity Working Group (OWG 2)
- Established the Obesity Working Group 2 to carryout the short-term and long-term recommendations for dealing with the Nation's obesity problem set forth by OWG 1 in FY 2004. A detailed matrix of the status of the OWG 1 Report recommendations has been maintained and updated.
Consumer Knowledge of Trans fats, Saturated fats and Omega-3 fats
- Collected, compiled and analyzed baseline data begun in FY 2004 for these fats and acids. The 2004 Health and Diet Survey Supplement surveyed consumer awareness of fatty acids (saturated, trans, and omega-3) and their knowledge of the link between fatty acid consumption and risk for coronary heart disease.
FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health
Salmonella in Sprouts
- Evaluated a testing protocol for the recovery of Salmonella in sprout seeds. This work has now been completed and this improvement has been recommended for use as a pre-enrichment method to use with a Salmonella culture method to isolate Salmonella from alfalfa seed.
Dioxin Analysis Results/Exposure Estimates
- Published on the CFSAN Web site "FDA Analysis of Food and Feed for Dioxin-like Compounds (DLC)." This analysis was completed as part of specific goals for FDA's Dioxin Monitoring Program to obtain baseline data for DLC levels in food and animal feed ingredients susceptible to DLC contamination and to determine opportunities for DLC reduction by identifying contamination sources that can be eliminated or significantly reduced.
Peanut Protein Test Kits
- Initiated an Association of Official Analytical Chemist (AOAC) interlab study for immunochemical peanut protein test kits. CFSAN is working closely with AOAC International to evaluate validation study test results conducted by the European Standards Organization (CEN) test kits for the detection of peanuts in food products.
FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight
Food Facility Registration Final Rule
- Published in the Federal Register a final rule entitled: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Establishment and Maintenance of Records Final Rule
- Published in the Federal Register a final regulation entitled: "Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The final regulation requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States.
Establishment and Maintenance of Records Small Entity Compliance Guide
- Published a Small Entity Compliance Guide as a booklet entitled: "What You Need to Know About Establishment and Maintenance of Records." This booklet informs domestic persons in the U.S. who manufacture, process, pack, transport, distribute, receive, hold or import food for humans or animals, and foreign persons who transport food in the U.S., about a final regulation that establishes requirements regarding the establishment and maintenance of records.
Administrative Detention Guidance to Industry
- Published guidance entitled: "What You Need to Know About Administrative Detention of Foods." This guidance informs food manufacturers, processors, packers, transporters, importers and exporters about expedited procedures for perishable foods, as well as procedures describing how FDA will detain an article of food and the process for appealing a detention order.
Furan Action Plan
- Issued an Action Plan for Furan in Food. The action plan outlines FDA's accomplishments, goals, and planned activities on the finding of furan in food, and it will guide FDA's activities on the issue of furan over the next several years. Some animal data suggest that high levels of furan exposure might have a carginogenic effect in humans, but its true effect on humans at low levels is not known.
Furan in Food
- Published on the CFSAN Web site expanded exploratory data on furan in food. FDA is now posting furan data that were collected through November 18, 2004. Data are presented in chronological order with data collected between June 10, 2004 and November 18, 2004. FDA is presenting these data to inform the public of FDA's progress and to help stimulate research into the formation of furan in food. The results reflect furan levels detected in samples of individual food products.
NACMCF Report on Ready-to-Eat Foods
- Published a report advising on the necessary scientific parameters for establishing safety-based use-by-date labels for refrigerated ready-to-eat foods to help reduce the incidence of foodborne listeriosis. A copy of the Report can be viewed at: http://www.fsis/usda.gov/ophs/nacmcf/2004/NACMCF. House Report 108-193 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2005 Appropriations Language directed FDA to provide the Appropriations Committee a copy of the report by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).
Acrylamide in Food
- Published on the CFSAN Website expanded exploratory data on acrylamide in food. This is part of FDA's continued efforts to investigate how acrylamide is formed in food, seek to identify ways to reduce acrylamide levels, and study the human health risk of consuming acrylamide in food. Acrylamide can cause cancer in laboratory animals at high doses, but it is not clear if it causes cancer at much lower levels in food.
- Completed an evaluation of program performance through the sixth year, with an emphasis on identifying factors that may be inhibiting improvements in compliance rates. Based on FDA's historical compliance classification system, approximately 91% of firms were in compliance through the sixth year of the Seafood HACCP Program. This is a significant increase over the 85% compliance rate of 2001.
- Published a report entitled: "Food cGMP Modernization - A Focus On Food Safety." The report summarizes the comments, both written and oral, that were offered to the Agency in response to its Federal Register notices and during three public meetings. The report addresses the major opportunities for modernization of the food cGMPs as suggested by the respondents.
Guidance on Enforcement Discretion for Ozonation of Juice
- Issued guidance for industry entitled "Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes." This guidance addresses the use of ozone to treat apple juice to meet the pathogen reduction requirements of 21 CFR Part 120 "Hazard Analysis and Critical Control Point (HACCP) Systems" (the juice HACCP regulation) and 21 CFR 101.17(g) "Juices that have not been specifically processed to prevent, reduce, or eliminate the presence of pathogens" (the juice labeling regulation). The guidance notes that FDA is currently unaware of any validated treatments for juice using ozone.
Final Rule for Arsenic in Bottled Water
- Published in the Federal Register a final regulation for arsenic levels in bottled water. The final regulation requires manufacturers to monitor their finished bottled water products for arsenic at least once each year and to monitor their source water for arsenic as often as necessary, but at least once every year.
Final Generic "Channels of Trade" Guidance
- Published in the Federal Register 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 Pursuant to Dietary Risk Considerations." This guidance presents FDA's general policy for implementing the channels of trade provision in the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, for food containing residues of pesticide chemicals, for which tolerances have been revoked, suspended, or modified pursuant to dietary risk considerations.
- Published several amendments to a July 2004, interim final rule on bovine spongiform encephalopathy (BSE) entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics
- Amended the interim final rule to allow use of the small intestine in human food and cosmetics, provided that the distal ileum has been removed. The amendments also clarify that milk and milk products, hides and hide-derived products, and tallow derivatives are not prohibited for use in human food and cosmetics.
- Published in the Federal Register an amendment to the regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim "healthy.'' The Agency is retaining the currently effective, less restrictive, "irst-tier'' sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the ``second-tier'' (more restrictive) sodium level requirements for all food categories.
- Determined that requiring the more restrictive sodium levels would likely inhibit the development of new "healthy'' food products and risk substantially eliminating existing "healthy'' products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term ``healthy'' will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients.
- Revised the regulatory text of the ``healthy'' regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for "healthy'' into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.
Dietary Supplements: Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA)
- Published in the Federal Register (69 FR 64957) the strategy for the further implementation of DSHEA. The strategy sets forth a series of specific, integrated research and regulatory measures, including guidance, regulations, and science-based compliance and enforcement mechanisms. By implementing these measures, CFSAN hopes to improve the transparency, predictability, and consistency of both its scientific evaluations of dietary supplement products and ingredient safety, and of its regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false or misleading claims. CFSAN expects that this improved transparency will help engage stakeholders in developing further measures to implement DSHEA.
Dietary Supplement Labeling Guide
- Published on the CFSAN Web site guidance for industry entitled: "A Dietary Supplement Labeling Guide." This guide was prepared to help assure that dietary supplements sold in the U.S. are properly labeled. This guide applies to dietary supplements produced domestically as well as those produced in foreign countries.
Alpha Hydroxy Acids Guidance
- Published in the Federal Register a guidance document entitled: "Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients." This guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients.
Report to Congress - Perchlorate Survey
- Completed report and submitted to Congress. Senate Report 108-340 of the Agriculture Rural Development, Food and Drug Administration and Related Agencies 2005 Appropriations Language directed FDA to report on the findings of the CFSAN perchlorate surveys of food and bottled water.
FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century
- Held approximately 20 meetings about FALCPA with groups representing consumers, state and local regulators, and various food industries.
Field Program Selected Accomplishments
The FDA promotes and protects the public health by ensuring that the food supply is safe, sanitary, wholesome and honestly and properly labeled; and, that cosmetic products are safe and properly labeled. The Field supports the Foods program through a variety of activities. Examples of accomplishments and activities appear below organized by strategic goal.
FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight
Food Emergency Response Network (FERN)
- Currently, there are 123 laboratories representing 50 States and Puerto Rico that have satisfactorily completed the FERN Laboratory Qualification Checklist.
- Awarded eight cooperative agreements to state laboratories to support additional capacity for food analysis related to chemical terrorism and to enhance state, local, and tribal food safety and security efforts
- Participated in two FDA surveillance assignments, the Food Security Surveillance Assignment and the Interstate Travel Program Water Assignment.
- Issued six proficiency test samples including one joint proficiency test sample with CDC/LRN for microbiology laboratory testing of Bacillus anthracis; three chemistry proficiency test samples; and, two radiological proficiency test samples.
- Conducted five FERN training courses.
Food Security Surveillance Assignment
- Collaboration with forty-four states and the Commonwealth of Puerto Rico conducted a Food Security Surveillance Assignment (FSSA) for six weeks. The primary goals of the FSSA were to deter intentional contamination of the food supply through heightened and targeted preventive activities at various points in the food distribution chain and to exercise the systems and networks for responding to a food related emergency during a period of increased food security risk.
- Took possession of two completed mobile laboratories in April 2005: one for microbiological sample analysis; and, the second for chemical sample analysis.
- Trained 30 FDA laboratory personnel havebeen in the mobile laboratory platform.
- Ran a test deployment of the mobile laboratories at NCTR to demonstrate that analysts were able to set up the laboratories ona location site and run sample analyses using only the mobile laboratory facilities.
State Contracts, Grants and Partnership Programs
- Awarded contracts with state and local governments to perform food safety, domestic seafood HACCP, and juice HACCP inspections. ORA also implemented electronic State Access to FACTS (eSAF) in 15 state food programs and conducted the associated training for FDA and state personnel. Audits were completed of all state food inspectors working under contract. Pilot tested an audit program for contracts with New York State.
- Awarded Cooperative Agreement grants for Food Safety projects in 34 states; and, awarded new grants for Health Fraud prevention projects in 11 states. ORA also provided Conference Grants to six National Conferences, i.e., the Association of Food and Drug Officials to provide for State and local agency personnel to attend national meetings.
- Maintained and continued to develop new partnerships (e.g., seafood HACCP inspections) that have contributed to the exchange of inspection and sampling data and have facilitated the receipt of training and distribution of equipment to the states.
FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products
Ephedra-Containing Dietary Supplements
- Identified more than thirty internet and retail firms selling banned ephedra products
- Conducted investigations to identify physical locations and other information for regulatory action to uphold the ban on ephedra containing products.
|PROGRAM WORKLOAD AND OUTPUTS||FY 2005 Actual||FY 2006 Estimate||FY 2007 Estimate|
FOOD & COLOR ADDITIVE PETITIONS*
|Petitions Reviewed **||14||12||10**|
* Beginning in FY 2007, this program will include petitions for food contact substances. We expect the number of petitions received to increase in subsequent years to at least 60-90 incoming petitions, because of the elimination of the food contact substance notification program..
**Number reviewed includes those approved, withdrawn, or placed in abeyance because of deficiencies during the FY.
PREMARKET NOTIFICATIONS FOR FOOD CONTACT SUBSTANCES**
|Notifications Reviewed *||73||110**||0|
* Number reviewed includes those that became effective or were withdrawn.
** FDAMA established a notification program for food additives that are food contact substances (e.g. packaging materials). The number of "notifications reviewed" appears to be the same, in some instances, because under the provisions of this notification, a food contact substance may be marketed 120 days after notification unless the agency objects. Due to strategic re-deployment, beginning in FY 2007, this program will be eliminated and will result in the statutorily mandated safety review for food contact substances having to be submitted through the rulemaking process for food and color additives.
INFANT FORMULA NOTIFICATIONS
|Notifications Received *||21||30||35|
|Notifications Reviewed **||21||30||35|
|FDA Review Time||90 Days||90 Days||90 Days|
* Number of submissions received in current FY include some received late in the FY.
** Number of submissions reviewed includes some submissions that were received in the previous FY.
|Submissions Received a||66||75||83|
|Submissions Reviewed b||68||75||83|
|FDA Review Time||75 Days||75 Days||75 Days|
*** A single notification may address one or more new dietary ingredients. For example, FDA as received at least 15 notifications that pertain to 2 up to 16 new dietary ingredients in a single notification
a Number of submissions received in current FY includes some received late in the FY that will be completed in the next FY when the due date occurs.
b Number of submissions reviewed in the current FY includes some submissions that were received in the previous FY when the due date occurred in the current FY.
|FIELD FOODS PROGRAM OUTPUTS-DOMESTIC INSPECTIONS||FY 2005 Actual||FY2006 Estimate||FY2007 Estimate|
|Domestic Food Safety Program Inspections||4,573||3,400||3,400|
|Imported and Domestic Cheese Program Inspections||477||400||400|
|Domestic Low Acid Canned Foods/ Acidified Foods Inspections||481||400||400|
|Domestic Fish & Fishery Products (HACCP) Inspections||2,467||2,480||2,480|
|Import (Seafood Program Including HACCP) Inspections||500||500||500|
|Juice HACCP Inspection Program (HACCP)||490||375||375|
|Interstate Travel Sanitation (ITS) Inspections||1,510||1,700||1,700|
|State Contract Food Safety ( Non HACCP) Inspections||6,992||8,130||8,130|
|State Contract Domestic Seafood HACCP Inspections||953||1,135||1,135|
|State Contract Juice HAACP||47||35||35|
|State Partnership Inspections||1,284||1,300||1,300|
|Total Above FDA and State Contract Inspections||19,774||19,855||19,855|
|Total Domestic Reinspections (Non-add)||523||523||523|
|State Contract and Grant Foods Funding||$6,825,000||$7,100,000||$6,940,000|
|Number of FERN State Laboratories||8||10||16|
|Annual FERN State Cooperative Agreements/Operations||$12,270,000||$7,037,000||$12,236,000|
|Total State & Annual FERN Funding||$19,095,000||$14,137,000||$19,176,000|
|Domestic Field Exams/Tests||3,528||5,000||5,000|
|Domestic Laboratory Samples Analyzed||15,390||11,425||9,425|
|All Foreign Inspections||129||200||100|
|Total Foreign Reinspections (Non-add)||15||15||15|
|Import Field Exams/Tests||84,997||75,000||71,000|
|Import Laboratory Samples Analyzed||25,549||31,600||29,600|
|Import Physical Exam Subtotal||110,546||106,600||100,600|
|Import Line Decisions||8,672,168||10,059,715||11,669,269|
|Percent of Import Lines Physically Examined||1.27%||1.06%||0.86%|
|Prior Notice Security Import Reviews||
|(Bioterrorism Act mandate)||86,187||45,000||60,000|