Foods

¹/ Reflects enacted levels adjusted for the 0.22 percent rescission, accounting for $628,000 in the Foods program.
^2/ Reflects decrease in base funding from FY 2001 of $324,000, for Human Subject Protection and Bioterrorism.
^3/ Pay increases shown on separate line, and not reflected in individual increase areas.
^4/ Includes $1,497,000 reduction to a Congressional earmark provided in FY 2001.

Historical Funding and FTE Levels

MISSION

• Ensure the food supply is 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 before they go on the market to ensure their safety and effectiveness.
• Research ways to provide the necessary basis for regulatory decisions.
• Assure the quality of foods, food ingredients, dietary supplements and cosmetics that are available on the market.
• Identify food-related health hazards.
• Take corrective action to reduce human exposure to these hazards and the possibility of food-related illnesses and injuries.
• Educate and train consumers and industry on food safety.

REQUESTED INCREASES

Pay Increase  + $11,488,000

FDA’s request for funds to cover pay cost increases is vital to the Agency because personnel are so essential to accomplishing its mission.  Pay increases have a major impact on FDA because the Agency is more people-intensive than many other government agencies.  Payroll accounts for over 60 percent of the total FDA budget.  This has a significant impact on all activities in FDA, particularly the field.  The costs of the pay increases are necessary to ensure the integrity of the Agency's work for the Foods Program for review of food additive petitions and other premarket activities including dietary supplements, and the field labor force for inspections and compliance functions for foreign and domestic inspections, and import surveillance.

In order to maintain the level of activities carried out in FY 2001, FDA is requesting $40,000,000 million to cover the cost of the FY 2002 pay raise, annualization of the FY 2001 pay raise, anticipated within grade increases, and one extra day of pay.  The Foods Program portion of this increase is $11,488,000.

Bovine Spongiform Encephalopathy (BSE) + $1,100,000 and 5 FTE

Under the Federal Food, Drug, and Cosmetic (FFD&C) Act (Sec. 704), FDA is granted general authority to inspect food establishments, and under FFD&C Act (Sec. 903), the Agency shall be responsible for research relating to foods and cosmetics in carrying out this Act.

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: the most well 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. FDA will use the increased resources to:

• Expand work efforts to identify food and cosmetic products containing brain, spinal cord, and other specific risk materials (SRMs); the origin of the animal; and country of origin;
• Research the risk factors and mechanism for CWD, which affects elk, deer and other domestic game/pen-reared animals;
• Identify infectious agents in foods; and,
• Participate in international BSE meetings to ensure safety of the U.S. food supply; and provide up-to-date information on the emerging public health issues to the public.

Imports & Inspections + $10,397,000 and 37 FTE (Budget Authority + $2,297,000 and 11 FTE; User Fees + $8,100,000 and 26 FTE)

Under the Federal Food, Drug, and Cosmetic (FFD&C) Act (Sec. 704), FDA is granted general authority to inspect food establishments; under FFD&C Act (Sec. 903), the Agency shall be responsible for research relating to foods and cosmetics in carrying out this Act; and, under FFD&C Act (Sec. 801 and 803), the Agency shall assess potentially violative imports, enhance the safety of imported products through surveillance at the border, and provide that source country quality systems/standards/audits conform to the requirements of the FFD&C Act.  

Budget Authority

FDA is responsible for ensuring the safety of products produced and distributed by more than 60,000 domestic establishments. The Agency uses its inspectional authority, as directed by statute, to provide this assurance.  FDA is requesting additional resources to:

• Advance FDA's egg safety, as well as compliance and enforcement programs;
• Conduct additional domestic inspections for the Food Safety Initiative (FSI) and increase laboratory samples analyzed by 360 for a total of 6,340; and,
• Increase resources used to support foreign inspections so that the Agency can further assure that products offered for import are safe, effective, and properly labeled.

Proposed User Fees

FDA is also responsible for ensuring the safety of over six million import line entries that cross our borders annually. This will grow to 7 million in FY 2001.  The sources of these entries are diversified and include increasingly more products from countries that are typically categorized as emerging economies, with emerging regulatory infrastructures.

FDA proposes to collect $8,100,000 in additive import user fees within the Foods program to fund the Operational and Administrative System for Import Support (OASIS), and other import work.   The OASIS system enables FDA to substantially reduce the risk of potentially harmful foods and other imported products reaching the American marketplace.  The importer/broker community benefits through faster turn-around times, elimination of large volumes of paperwork, and reduced costs of doing business.   OASIS will give FDA staff access to historical information to better target products and firms at high risk, the ability to plan inspections more effectively, and the ability to share findings from inspection and lab analyses with other offices.   With the additional resources, FDA will:

• Modernize the Operational and Administrative System for Import Support (OASIS) import data processing system so that import reviewers will have more rapid and direct access to information necessary for entry decisions about food products, in particular perishable items;
• Implement enforcement strategies for imported foods to improve compliance with and monitoring of Hazard Analysis Critical Control Points (HACCP) Programs and food safety regulations;
• Increase import field exams of imported foods and dietary supplements;
• Expand import entry reviews to keep pace with the increase in import line entries;
• Update on a risk basis the criteria that determines which import line entries are selected for on screen review and increase the frequency of on-screen review;
• Increase FDA data audits, import filer training, and liaison activities to improve the integrity of import data submitted by import filers; and,
• Increase coordination with the U.S. Customs Service to improve the effectiveness of cargo control activities at ports, and monitor food products that have been refused entry pending exportation or destruction (follow-up on refusals).

Patient Safety/AERS + $1,000,000 and 4 FTE

Under the Federal Food, Drug, and Cosmetic (FFD&C) Act (Sec. 903), the Agency shall be responsible for research relating to foods and cosmetics in carrying out this Act, as well as having primary regulatory responsibility for ensuring the safety of ingredients used in dietary supplements.

FDA currently uses several post-marketing surveillance systems for both mandatory and voluntary adverse event reporting associated with foods, cosmetics and dietary supplements.  These systems are not optimal because they operate independently and data is not easily shared.  Further, the need to share data with other FDA programs is critical for determining if action is needed, particularly with dietary supplements where adverse events are often reported through the Human Drugs Program.   FDA will apply the requested funding to:

• Consolidate five existing Adverse Event systems within the Foods Program into one comprehensive, center-wide system to capture and evaluate consumer adverse event reports for foods, food and color additives, cosmetics, and dietary supplements;
• Develop external interfaces with the Agency wide Field Accomplishments Tracking System (FACTS) and AERS to share data; and,
• Supply system users with classification, indexing, research and management tools, and materials for the evaluation of adverse events.

Food Safety  + $12,700,000 and 58 FTE (Budget Authority + $7,400,000 and 35 FTE; User Fees  + $5,300,000 and 23 FTE)

Under the Federal Food, Drug, and Cosmetic (FFD&C) Act (Sec. 704), FDA is granted general authority to inspect food establishments and under FFD&C Act (Sec. 903), the Agency shall be responsible for research relating to foods and cosmetics in carrying out this Act.

Budget Authority

FY 2002 will mark the fifth year of the highly successful multi-agency Food Safety Initiative (FSI) to control and reduce food borne pathogens in the American food supply.  The benefits of this investment are clear: an overall decline of 16 percent in food borne illnesses in America.  For certain of the most dangerous pathogens, the reductions are even more pronounced.  For example, E. coli 0157:H7 and Campylobacter fell by 26 percent, Shigella by 44 percent, Salmonella enteritidis by 48 percent, and Cyclospora by 70 percent.

The FY 2002 FSI Strategic Plan overall goal is to protect public health by significantly reducing the prevalence of pathogens, and expanding coverage to pesticides and chemical contaminant hazards, thereby reducing acute and chronic illnesses and injuries through science-based and coordinated regulation, inspection, enforcement, research, and education programs.  In support of this effort, FDA will devote its increased resources to the following activities:

• Expand current laboratory capacity to increase sample analysis needed for HACCP verification, food sanitation, and food and color additive reviews and audits and other activities;
• Increase activities related to foods using biotechnology;
• Collect and analyze food samples for pesticides, heavy metals and dioxins;
• Evaluate the risks of pesticides and chemical contaminants, and the level of food nutrients in the American diet through a revised FDA Total Diet Program which will provide data on levels of pesticides, industrial chemical, toxic elements, and vitamins and minerals in foods that is more representative of today's consumer eating habits;
• Inspect at least 95 percent of domestic firms annually for high-risk food establishments, currently projected at 7,000 for FY 2002;
• Increase the number of domestic inspections (non-HACCP and Seafood HACCP) by State contract by almost 1,100, for a total of 5,300;
• Expand State audit inspections, enforcement, and data reporting for State inspectional and compliance activities so the States can enter inspection information directly into field data systems; and,
• Expand domestic sample analyses for food borne pathogens and contaminants within the food supply and pathogen tracking (eLexnet).

Proposed User Fee
Food Export Certificates

• Section 801 (e)(4)(B) of the Federal Food, Drug, and Cosmetic Act authorizes user fees for export certificates for drugs, animal drugs, and devices.   The requirements for these certificates were amended by the FDA Export Reform and Enhancement Act of 1996, which also established user fees for this service.  This section does not cover collection of user fees for export certificates for foods.
• Collection of user fees for food export certificates will enable FDA to fully support this program, and limit the current redirecting of existing monies from other critical food safety programs.  Under this provision, FDA expects to issue approximately 30,000 export certificates per year at a cost of $175 per export certificate.   Private sector exporters would bear the cost of the program but reap the benefits through the Agency's enhanced ability to facilitate product exports in compliance with the importing countries' requirements.   Field staff will continue to prepare export certificates on a timely basis to expedite trade, and in the languages required by current international agreements.
• FDA currently incurs costs in the millions of dollars to support the specific needs of U.S. food exporters.  By law, FDA is required to issue certificates to any person wishing to export a drug, animal drug, or device, that the product to be exported meets certain requirements of the law.  Food exporters are required to comply with an increasing number of European Union (EU) requirements for certificates attesting to the safety of animal-derived foods.   Such certificates attest to product compliance with EU directives and standards, not FDA regulations.   If FDA does not receive authority to collect the user fees for export certificates for foods, FDA will continue to spend millions of dollars in food safety resources to support the specific needs of U.S. food exporters instead of supporting food safety activities that benefit the entire population.

JUSTIFICATION OF BASE

Activities Related to Increases for FY 2002
Payroll

• FDA's Foods Program has primary responsibility for assuring that the food supply of the U.S. is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. Since foods continue to be susceptible to an ever-growing variety of potentially hazardous substances including microbial pathogens, chemical residues, natural toxins, and illegal food additives, FDA has an enormous responsibility that has a direct impact on the health of every man, woman and child in the nation.  Base resources will be devoted to meet these responsibilities.
• The field component of Foods inspects regulated industry, and collects and analyzes samples.  Other activities that often arise are review and management of enforcement actions, and consumer complaints, trace back efforts to determine the cause of food borne illness outbreaks, and review of import entries for admissibility decisions.  These functions are inherently governmental and highly personnel intensive.

Bovine Spongiform Encephalopathy (BSE)

• Study options for addressing the risk posed by BSE for dietary supplements, such as a regulation for certifying source material, an Import Alert for all dietary supplement materials of sheep, goat or bovine origin, and an abbreviated good manufacturing practices (GMP) regulation.
• Revise Import Alert #1704, "Detention without Physical Examination of Bulk Shipments of High-risk Bovine Tissue from BSE Countries" to ensure that all imported products regulated by CFSAN that may contain infective tissues are detained without physical examination until they can be more fully evaluated.  This revision is being done in cooperation with other FDA Centers and Department of Agriculture Animal Plant Health Inspection Service to ensure an inclusive import alert.

Imports and Inspections

• Conduct approximately 250 foreign inspections, with top priority to "high-risk" foods.
• Implement the FDA and U.S. Customs Service joint Action Plan to better leverage resources to enhance the safety of imported products through surveillance at the border.
• Fund domestic inspections (Food Safety Initiative) at the following levels:

–10,900 inspections conducted by FDA;
– 4,202 inspections conducted by State contracts; and,
– 1,400 inspections conducted by State partnerships.    

• Review more than 4,500,000 import line entries for admissibility into domestic commerce.

Patient Safety/AERS

• Provide training for field staff to improve the information gathered through investigation of consumer complaints.
• Upgrade field data systems to provide improved consumer complaint data.

Food Safety

• Implement our three-year strategy to enhance FDA audit and evaluation of State inspection programs, and increase the rate of State contract audit inspections to ensure consistent application of regulations nationwide by FDA and the States.
• Inspect at least 90 percent of domestic firms annually for high-risk food establishments, currently identified at 6,250, including associated laboratory support for sample analysis.   High-risk firms include processors of infant formula, ready to eat foods, produce, seafood products, low-acid canned foods, and juice.
• Replace outdated field laboratory equipment to improve the accuracy and timeliness of food product analyses to determine compliance with safety requirements.
• Expand the ability of Federal, State and local partnerships to improve food safety through better data sharing with our partners in the States.  The FACTS (Field Accomplishment and Compliance Tracking System) data system was enhanced so that States will enter data directly in the system in FY 2002.

Other Activities Related to Priority Areas

Biotechnology

• Publish biotechnology notification proposal, and draft guidance for voluntary labeling of foods that have or have not been developed using biotechnology.   
• Issue guidance to industry on assessing allergenicity in genetically engineered food products.

Dietary Supplements

• Respond to 95 percent of premarket notifications for new dietary ingredients within the statutory time frame (75 days).
• Review the 30-day postmarket notifications for structure/function claims in a timely manner.
• Collaborate across the Agency to publish a proposal for labeling dietary supplements for women who are or may become pregnant.
• Publish dietary supplement GMP proposed rule and conduct an outreach program.
• Collaborate on dietary supplement research with the National Center for Natural Products Research in Oxford, Mississippi as well as with the National Academy of Sciences' Institute of Medicine to review dietary supplement safety.

International Activities

• Participate in and raise visibility in the 17 Codex committees, ad hoc task forces and related drafting and working groups and scientific advisory committees (i.e., Joint Expert Committee on Food Additives (JECFA)) to ensure that source country standards, quality systems, and audits conform to the requirements of the FFD&C Act.

Bioterrorism

• Develop a threat assessment for the food supply.  This includes a review of threat agents, targets, federal and state food inspection policies and procedures, and industry practices to prioritize the use of resources to prevent and prepare for terrorist threats against the food supply.

Premarket Activities  

• 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.
• Develop standards for premarket review of new products and emerging technologies - e.g., genetically modified foods, dietary supplements, infant formulas and medical foods to ensure that foods are properly labeled when there is a significant change in the modified food as compared to the traditional. Examples of significant changes include a nutritional change, compositional change, change in the condition of use, or when an allergenic component has been introduced in a food where it is not present in the traditional food.
• Improve the premarket review process for food and color additives using advanced computer and telecommunications technologies.
• Provide pre-filing assistance to petitioners through the publication of detailed guidance for food contact substances and food color additives.
• Target sampling and analysis of fresh produce through the development of Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs).
• Provide technical assistance and education programs for foreign and domestic producers.

Selected FY 2000 Accomplishments

Imports

• Conducted 160 inspections of foreign food establishments (non-HACCP), almost double the number completed in FY 1999.
• Completed the collection and laboratory analysis of 1,000 samples of high volume imported produce for microbiological pathogens, which provided very useful data.  Forty-four samples were found to be positive and detained for microbial contamination.  Thirty-five samples were positive for Salmonella and nine positive for Shigella.  There have been no positive samples for E. coli 0157:H7. Twenty-two firms have been placed on Detention Without Physical Examination (DWPE).  Subsequently, 11 have been removed from DWPE.  Four foreign farm inspections have been conducted as a result of follow-up investigations.
• Began improving OASIS through software modifications which included important new functionality such as supervisory review and proxy functions.  The new features enhanced and expedited import review and developed and implemented a new screening process in OASIS which allows for the expedited automated review of FDA regulated import products using more specific criteria then was previously possible under the U.S. Customs Service system.

Domestic Inspections

• Conducted approximately 5,700 "high-risk" food inspections, an increase of 90 percent over the FY 1999 level of 3,000.
• Established DNA finger printing to combat food borne outbreaks using pulsed field gel electrophoresis (PFGE) capability in five field laboratories because it provides timely identification of the source of contamination.  This technique has been successfully used in several outbreak situations involving Salmonella and Listeria monocytogenes.
• Established a program to screen Salmonella isolates from foods.  In FY 2000, about 250 Salmonella isolates were screened and several multiple-antibiotic resistant strains were found.
• Tracked and investigated 98 pathogen-related incidents.  Examples of food borne pathogens tracked which spread across several states include a “salmonella meunchen outbreak” in mangoes that broke out in 13 states; a norwalk-like virus in potato salad that occurred in 11 states; and, a salmonella anatum outbreak which occurred in frozen carrots and peas that occurred in eight states and Canada.

HACCP

• Conducted seafood HACCP inspections and sent 148 seafood HACCP Warning Letters.  The Agency pursued the first seafood HACCP injunction against a purveyor of hot and cold smoked fish because the firm was not controlling the hazard of Clostridium botulinum.   The firm entered into a consent decree and agreed to stop processing until this hazard could be controlled.
• Initiated a Dairy Grade A HACCP Pilot Program in collaboration with the National Conference of Interstate Milk Shippers (NCIMS), in six dairy processing plants. The six pilot plants have implemented the voluntary HACCP Pilot and were listed in the Interstate Milk Shippers List under the HACCP alternative to the traditional Pasteurized Milk Ordinance-based program.

Produce

• Worked with USDA's National Agricultural Statistical Service (NASS) to perform an extensive survey of production practices of fresh fruit and vegetable growers and packers in the U.S. to measure adoption of Good Agricultural Practices (GAP)/Good Manufacturing Practices (GMP) guidance. This survey gathered data on the types of practices (e.g., agricultural water source, manure use, employee hygiene and facility sanitation) covered in the guide. A report of the survey results is expected to be available in early 2001.

Food Code Adoption

• Exceeded goal that 35 percent of States would adopt the Food Code.  Twenty State agencies having jurisdiction over retail-level establishments have adopted the Food Code.
• Providing model food codes and model code interpretations and opinions is the mechanism through which FDA, as a lead federal food control agency, promotes uniform implementation of national food regulatory policy. 

Harmonize Standards for E. coli O157: H7

• Provided funding, in conjunction with USDA, for a pilot project with eight Federal, State and Local laboratories to develop standards for sampling and testing methods for E. coli 0157:H7. The pilot is taking E. coli O157: H7 food sample testing currently being done at the labs and standardizing their methods, as well as working toward accreditation of the procedures used.  The pilot will be completed in FY 2001.

Risk Communication Education and Training

• Conducted U.S. - Chile Seminar on Food Safety entitled "An Integrated Food Safety System; Processes and Partnerships".  JIFSAN in conjunction with the Government of Chile held a training program on produce safety, emphasizing GAPs.  FDA also conducted dairy farm sanitation and milk safety training, emphasizing on-farm practices, in San Salvador, El Salvador.  Foreign outreach and education was continued by co-sponsoring a regional food safety meeting in Auckland, New Zealand.
• Funded 19 State Food Safety Task Forces with Small Conference Grants totaling $96,500 and awarded 13 grants totaling $530,000 for Innovative Food Safety Projects to State and local regulatory agencies that were intended to complement, develop and/or improve State and local food safety programs.
• Awarded 39 state food contracts for over 5,100 food inspections for a total of $2,617,000.

Premarket Review of Food and Color Additives and Food Ingredients

• Completed the safety evaluation in less than 360 days for all five food and color additive petitions that qualified for expedited review. This exceeded FDA's goal to complete 80-90 percent of these petitions within 360 days.
• Completed the safety evaluation in less than 360 days for 77 percent (59 of 77) of food and color additive petitions that did not qualify for expedited review.   This exceeded FDA's goal to complete 50 - 60 percent of these petitions within 360 days.
• Developed guidance for the industry on preparation of premarket notification for food contact substances.
• Published a final rule on the simultaneous review of food ingredients in meat and poultry.

Nutrition, Health Claims and Labeling

• Received 10 new infant formula notifications, and all were reviewed within the 90-day statutory time frame.
• Published a final rule authorizing a health claim for soy protein and heart disease.   FDA completed the evaluation of two additional health claim petitions.  One petition was for sterol esters and heart disease. The other was for stanol esters and heart disease.  The Agency issued an interim final rule authorizing these health claims.

Dietary Supplements

• Communicated FDA concern about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. FDA issued separate letters to address different audiences.  The letter to the industry was to deter marketing of aristolochic acid and the one to health care professionals was to deter the issuance of prescription (use) containing aristolochic acid.  FDA issued an Import Alert on these products.
• Published three Federal Register notices announcing the availability of new adverse event reports and related information on dietary supplements containing ephedrine alkaloids, as well as announcing withdrawal of the provisions of the ephedrine alkaloids proposed rule relating to the dietary ingredient level and duration of use limit for these products.  FDA participated in a public meeting to discuss available information about the safety of dietary supplements containing ephedrine alkaloids.
• Eliminated the Freedom of Information (FOI) backlog that included requests for Special Nutritional/Adverse Events Monitoring System (SN/AEMS) information dating from 1998.
• Published a final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body.  CFSAN participated in an FDA public meeting addressing pregnancy-related claims under the structure/function rule. Over a ten-month period, FDA received approximately 1,400 structure/function notifications. After reviewing the notifications, the Agency sent 102 letters to firms notifying them that the claims for one or more of the products that were the subject of their notifications were not structure/function claims, but were disease claims not permitted for use in the labeling of dietary supplements pursuant to section 403(r)(6) of the FFD&C Act.
• Published a Federal Register notice on the strategy for responding to petitions for health claims for dietary supplements, including the health claims at issue in Shalala v. Pearson.   FDA held a public meeting on April 4, 2000 to solicit comments on implementation of the Pearson decision.
• Issued a final determination on the first, second, and third of the four Pearson claims.  FDA determined that the proposed claim that stated 0.8 mg of folic acid in a dietary supplement was more effective in reducing the risk of neural tube defects than a lower amount in foods was not authorized; determined that the proposed health claim about dietary fiber and reduced risk of colorectal cancer could not be authorized because the results of studies about dietary fiber consistently showed a lack of relationship between dietary fiber supplements and the risk of colorectal cancer; and determined enforcement discretion to allow a qualified claim about the use of omega-3 fatty acids in dietary supplements and the reduced risk of coronary heart disease. The qualified claim applies to daily intakes that do not exceed three grams per person per day from conventional food and dietary supplement sources.
• Issued the Dietary Supplement Strategy which plans to have, by the year 2010, a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, and that provides consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
• Initiated recalls of herbal products due to the presence of undeclared prescription diabetic drugs, glycuride, and phenformin.  Both drugs are used to lower blood sugar.  Recalls of such products involved Sino American Health Products, Inc.; Chinese Angel Health Products, Inc.; and, Diabetic Capital (U.S.) LLC.

Chemical and Other Contaminants

• Published a draft compliance policy guide (CPG) entitled, “Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin”. The purpose of the CPG is to advise FDA's field offices and the industry concerning enforcement actions that may be taken against apple juice products that contain patulin.
• Published a final report on the feasibility of appropriate methods of informing customers of the contents of bottled water, as required by the Safe Drinking Water Act (SDWA) Amendments.

Leveraging Scientific Expertise

• Restructured the Food Advisory Committee to consist of a "parent" Committee and four standing Subcommittees:  (1) Additives and Ingredients; (2) Contaminants and Natural Toxicants; (3) Dietary Supplements; and (4) Food Biotechnology.

Codex Committees and Working Groups

• Participated in 18 Codex committees and related meetings to promote development of harmonized food safety and labeling standards. In June 2000, FDA provided a leadership role for the Codex Committee on Nutrition and Foods for Special Dietary Uses in developing international Guidelines for Vitamin and Mineral Supplements. Specifically, FDA participated in the Ad-Hoc Task Force on Foods Derived from Biotechnology in July 2000, and participated in the Task Force's Working and Drafting Groups that are developing draft international Guidelines for the Safety Assessment of Foods Derived from Biotechnology.

Emerging Areas

• Issued a public announcement on plans to strengthen the regulatory approach for bioengineered foods. Three proposals were announced: (1) Development of a proposed rule requiring that developers of bioengineered foods notify the Agency before they market such products; (2) the addition of scientists to the Food Advisory Committee that have expertise in biotechnology; and (3) the development of labeling guidance to assist manufacturers who wish to voluntarily label their foods being made with or without the use of bioengineered ingredients.
• Held 14 public meetings to raise consumer and industry awareness to the presence of allergens in foods and on labeling approaches to identify the presence of allergens.

Foods
Program Activity Data

^1/The percentage of Food and Color Additive Petitions Completed is based upon 360 days.  The goals for first action for petitions (FY 2000 and FY 2001) are lower than those achieved in FY 1999 due to the conversion of petitions to notifications in FY 2000.  FDA will establish new baseline numbers for these goals.
^2/An inspection is any visit to an establishment during which all or part of one or more phases of that establishment's operation is evaluated against appropriate FDA requirements.
^3/Field Exams are the on-site examination of a product that is sufficient in itself to determine that the product is in compliance with FDA requirements.
^4/Laboratory samples analyzed are product samples physically analyzed by the laboratory to determine whether or not the product is in compliance with FDA requirements.

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