CFSAN 2005 Program Priorities
Report Card

Letter from Center Director
Attachment (summary chart and graph)
Final Report - Accomplished (summary list)
Report Card Table of Contents

---

Dear Colleague, FDA Foods Community:

I am pleased to provide you with the end-of-year report of our FY 2005 program priority accomplishments for FDA's foods program.  We had an ambitious plan this year and we completed 78% (87 out of 111) of our "A" List goals.  In a year of diminished resources, I am proud of the Center's success rate.  These results reflect a continued commitment to a management strategy of focusing our resources where we provide the most benefit to American consumers.

I would like to highlight a few program areas that I feel represent significant accomplishments this fiscal year for the Foods Program.  First, we have fully completed final rulemaking implementing three of the four provisions under the Public Health Security and Bioterrorism Act of 2002 (the BT Act).  I view this as a critical step in our goal of enhancing the security of the American food supply. 

CFSAN also has proposed to require shell egg producers to implement measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm.  We have taken this action because of the number of outbreaks of foodborne illnesses and deaths caused by SE that are associated with the consumption of shell eggs that have not been treated to destroy this pathogen.   We expect that the requirements that we have proposed in this rule will result in a significant decrease in the number of SE-contaminated eggs produced on farms.  CFSAN staff has developed the proposed requirements and we expect to publish the final rulemaking in FY 2006.

The Nutrition program remains one that we also will continue to revitalize and bolster.  In an effort to continue our commitment to address the Nation's obesity problem, FDA re-established the Obesity Working Group 2 (OWG 2) to continue work started in FY 2004 to implement recommendations of the "Calories Count" Report.   Our overarching goal is to make available more and better information about foods and dietary supplements, to help American consumers prevent diseases and improve their health by making sound dietary decisions. 

I am also delighted that we have taken positive steps forward in the area of food cGMPs.  We published a report entitled "Food cGMPs Modernization – A Focus on Food Safety."  The Report summarizes the comments on the foods cGMPs, both written and oral that was offered to the Agency by FDA's stakeholders.

Please note that these "A" List accomplishments represent specific objectives that we feel are critical to the mission of either the Center, the Agency or the Administration.  However, although we consider these accomplishments as important ones, ensuring a safe and secure U.S food supply requires adequate and appropriate preventive control systems for all foods.  We must do this through inspections, both domestic and foreign, sampling and analysis of food products, assisting other countries to produce safe food, training food handlers, educating consumers, reviewing food ingredients before they appear on the market, developing and implementing standards for safe foods, and conducting food-related research to improve our record of food safety.  We consider these activities as our continuous activities that we moved to the "Priority Ongoing Activities" section of the FY 2005 Program Priorities Document.  These activities utilize the majority of CFSAN resources and we are required to perform these activities on a year to year basis.  I am please to note that we continue to meet these obligations as well.

In closing, I would like to express my appreciation for the support I have received from our many stakeholders.  Your reviews and perspectives are invaluable to me in establishing our program priorities.  Working together we can improve public health.  I look forward to working with you and continuing the tradition of building predictability, transparency and accountability into FDA's foods program.

Sincerely,

Robert E. Brackett, Ph.D.
Director
Center for Food Safety and Applied Nutrition

Enclosures

---

FY 2005 Program Priority Status Report  

   

Final Report

Accomplished

---

Table of Contents

1.     Highlights

2. I. Ensuring Food Safety and Defense

   • Food Safety Implementing Regulations and Guidance
   • Imports
   • Seafood Safety
   • Foods cGMPs
   • Fruits and Vegetables
   • Egg Safety
   • Listeria
   • Cooperative Programs
   • Chemical Contaminants, Pesticides and Other Hazards
   • Transmissable Spongiform Encephalopathies (TSEs)
   • Game Meat
   • Food Allergens
   • Dairy Safety
   • Education

3. II. Improving Nutrition and Dietary Supplement Safety

   • Nutrition, Health Claims and Labeling
   • Dietary Supplements

4. III. Ensuring Cosmetic Safety

   • Cosmetics

5. IV. Ensuring Food Safety: Crosscutting Areas

   • Science Base
   • International
   • Internal Processes
   • Focused, Economic-based Regulations
   • Management Initiatives

---

Highlights
FY 2005 Program Priority Accomplishments
FDA's Center for Food Safety and Applied Nutrition

• Ensuring Food Defense:

  • Published final regulations for "Food Facility Registration"  and "Maintenance of Records" under the Bioterrorism Act.
  • Published Records Access and Administrative Detention Guidance to Industry.
  • Conducted outreach and training on the bioterrorism final rules.

• Improving Nutrition and Dietary Supplement Safety

  • Established Obesity Working Group 2 (OWG 2).
  • Developed strategy to further implement provision of DSHEA (Dietary Supplement Health and Education Act of 1994.
  • Published amendment to the regulation for the nutrient content claim "Healthy."

• Food Safety and other Program Activities

  • Published proposal for In Lid Labeling of Shell Eggs and developed a final rule requiring egg producers to implement measures to prevent Salmonella Enteritidis from contaminating eggs.  
  • Published a report on Food cGMPs.
  • Completed 2005 Retail Food Code.
  • Launched the "Food Safety for Moms-to-Be" bi-lingual public health education campaign.
  • Developed Furan Action Plan.
  • Published final rule for arsenic in bottled water.
  • Initiated implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA).
  • Served as major participant in international Codex activities:  Attended one Codex Commission Session meeting, a Trilateral U.S./Canada/Mexican Committee meeting; and provided the U.S. delegate for ten cross-cutting Codex Committees/Task Forces.

---

Part I: Ensuring Food Safety and Defense

Food Defense/Food Safety: Implementing Regulations and Guidance

1. 1.  Food Facility Registration Final Rule: On October 3, 2005, published in the Federal Register (70 FR 57505) a final rule entitled: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003.  The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003.  This final rule does not make any changes to the regulatory requirements established by the interim final rule.

   Federal Register (70 FR 57505)

2. 2.  Establishment and Maintenance of Records Final Rule: On December 9, 2004, published in the Federal Register (69 FR 71561) 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.

   Federal Register (69 FR 71561)

3. 3.  Records Access Guidance:  On December 9, 2004, announced in the Federal Register (69 FR 71657) the availability of a document entitled "Draft Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The draft guidance is intended to clarify the circumstances under which FDA may access and copy records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2003 (Bioterrorism Act) and establishes procedures to exercise its authority.

   Federal Register (69 FR 71657)

4. 4.  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.  Spanish and French versions published in May 2005.

      What You Need to Know About Establishment and Maintenance of Records (available in PDF)

5. 5.  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. 

   What You Need to Know About Administrative Detention of Foods (available in PDF, 305 Kb)

6. 6.  Bioterrorism Rule Outreach: Conducted nine (9) domestic meetings to discuss the final Recordkeeping regulation implementing Section 306 (Maintenance and inspection of Records) of the Bioterrorism Act of 2002.  The final Recordkeeping 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.

Imports

1. 7.  Imports Operations: Taken several steps in redesigning import operations and establishing processes and procedures to ensure import enforcement resources are results oriented, risk-based, and can be quickly redirected to meet emerging problems.  In FY 2005 FDA/CFSAN focused its efforts in understanding the current import activities taking place at the field and headquarters level, what drives these activities and what it would take to move import enforcement into areas with greater impact.  As part of these initial activities, the Center has provided direct reference authority to the field on certain salmonella detentions.   The Center has developed guiding principles for Imports Enforcement.

Seafood Safety

1. 8.  Good Aquaculture Practices: Submitted for publication papers based on data collected world-wide in preparation for drafting guidance on seafood Good Aquaculture Practices.  The paper is titled: "Salmonella sp. and the Sanitary Quality of Aquacultured Shrimp"  and was published in the December 2005 issue of the Journal of Food Protection.   The publication of guidance is being developed in the form of a "train-the-trainer" training course which is currently being developed in a collaborative effort with FDA/CFSAN, UMD, Virginia Tech, and JIFSAN.  It is expected to be completed and presented as a pilot training course in Thailand in the summer of 2006.
2. 9.  Vibrio parahaemolyticus Risk Assessment:  On July 20, 2005, announced in the Federal Register (70 FR 41772) the availability of the risk assessment: "Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters."   This quantitative risk assessment will help the agency evaluate risk mitigation strategies and develop effective guidance for the industry. 

   Federal Register (70 FR 41772)
   Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters.

3. 10.  Seafood HACCP: 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.

   FDA's Evaluation of the Seafood HACCP Program for Fiscal Years 2002/2003.

4. 11.  Environmental Working Group Information Quality Appeal: In May 2005, responded to the Environmental Working Group's (EWG) appeal to their Information Quality Act Request for Correction of the FDA Seafood Advisory Entitled: "What You Need to Know About Mercury in Fish and Shellfish."

Foods cGMPs

1. 12.  Foods cGMPs: On November 2, 2005, published report entitled: "Food cGMP Modernization – A Focus On Food Safety."  The report, prepared by the FDA's Food cGMP Modernization Working Group, 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.  The comments by stakeholders indicate that there is broad support for strengthening or including provisions for food safety and cGMP training, food allergen control, environmental controls for producers of high-risk ready-to-eat foods, and a requirement for written sanitation procedures.  The working group hopes that this report will help focus any further discussion on these issues, particularly as to the best means of implementing these preventive controls in a regulation.

   Food cGMP Modernization – A Focus On Food Safety

Fruits and Vegetables

1. 13.  Public Meeting on Sprout Safety: On May 17, 2005, held a public meeting to elicit information on the current science related to foodborne illness associated with the consumption of sprouts.  In October 2004, FDA released a produce safety action plan entitled ``Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption'' (Produce Action Plan).  One item in the Produce Action Plan is to initiate rulemaking to minimize foodborne illness associated with the consumption of sprouted seeds. 

   Federal Register Notice of Public Meeting (70 FR 20852).
   Meeting Transcript.

2. 14.  Salmonella in Sprouts: Evaluated a testing protocol for the recovery of Salmonella in sprout seeds.  The use of an effective pre-enrichment method with the BAM Salmonella culture method is essential to increasing the isolation rates of Salmonella from alfalfa seeds.  Comparisons of the isolation rates of Salmonella among different methods of pre-enrichment were used to identify the most effective pre-enrichment method.  These methods included (1) soaking, or direct inoculation of test portions into pre-enrichment broth, (2) dry blending test portions before inoculating into pre-enrichment broth, (3) wet blending test portions with the pre-enrichment broth, and (4) rinsing the test portions with the pre-enrichment broth.  This work has now been completed and this improvement has been recommended for use as a pre-enrichment method to use with the BAM Salmonella culture method to isolate Salmonella from alfalfa seed.
3. 15.  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. 

   Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction Purposes

4. 16.  Safe Juice Processing Video:  In November 2004, provided technical assistance to the California Department of Health Services, Food and Drug Branch, in cooperation with the Centers for Disease Control & Prevention, university researchers, and industry representatives, in the development of an educational video to assist the industry in producing safer juice. 

   Safe Juice Processing Video (order form).

Egg Safety

1. 17.  Egg Safety – In-lid Labeling:  On May 5, 2005, published in the Federal Register (70 FR 23813) 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 (PDP) or information panel.

   Federal Register (70 FR 23813)

2. 18.  Egg Safety Public Meetings: On September 22, 2004, published in the Federal Register (69 FR 56823) a proposed rule for egg safety national standards.  To solicit public comment on the proposed rule, FDA held three public meetings.  These meetings were held on October 28, 2004 - College Park, MD; November 9, 2004 -  Chicago IL and November 16, 2004 -  Los Angeles CA.  A transcript of the proceedings from these public meetings, as well as all information and data submitted voluntarily to FDA during the public meetings, will become part of the administrative record.
3. 19.  Egg Safety Final Rule: Summarized the comments received in response to the egg safety proposed rule published in the Federal Register (69 FR 56823) on September 22, 2004, and a workgroup was assembled to develop the final rule.  The workgroup drafted an issues resolution paper and have drafted the final rule.  The draft final rule is undergoing review and we expect the final rule to publish late FY 2006. 

Listeria

1. 20.  NACMCF Report on Ready-to-Eat Foods: 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) advising on the necessary scientific parameters for establishing safety-based us-by-date labels for refrigerated ready-to-eat foods to help reduce the incidence of foodborne listeriosis. 

   Considerations for Establishing Safety-Based Consume-by Date Labels for Refrigerated Ready-to-Eat Foods (available in PDF).

2. 21.  Unlawful Importation of Cheeses: Developed an action plan to address the large scale unlawful importation of cheeses.  The action plan was developed as a strategy.  The revision of Import Alert 12-03 to focus on soft cheeses from France and the development of the attachment listing restricting cheeses is a result of this action plan, as was a new attachment to the Domestic and Imported Cheese Compliance Program that provides a comprehensive list that prioritizes high risk cheeses for sampling.
3. 22.  Targeted Dairy Product Inspections: In collaboration with FDA's Office of Regulatory Affairs (ORA), issued and completed a field assignment that targeted several raw milk products.  Results of this assignment will be compiled and made available when all of the analytical work has been completed.
4. 23.  "Gourmet" Raw Milk Soft Cheeses: Developed a field assignment directing FDA's field force to conduct inspections of gourmet raw milk soft cheese firms.
5. 24.  Listeria Risk Assessment: On March 4, 2005, published in the Federal Register (70 FR 10650) a request for comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in smoked finfish (smoked finfish risk assessment), and evaluate the provisions of the 2001 Food Code that address preventive controls for L. monocytogenes in retail and foodservice establishments.  The smoked finfish risk assessment and the evaluation of the Food Code provisions for preventive controls for L. monocytogenes in retail and foodservice establishments support the agency's commitment to the Listeria Action Plan (revised 2003) that FDA and the Centers for Disease Control and Prevention (CDC) developed to reduce L. monocytogenes illnesses associated with the consumption of ready-to-eat (RTE) foods.

   Federal Register (70 FR 10650)

Cooperative Programs

1. 25.  2005 Food Code: On September 23, 2005, completed the 2005 FDA Retail Food Code. 

   2005 Food Code

2. 26.  State and Local Retail Food Regulatory Programs: Completed a commitment to increase the number of state and local Retail Food Regulatory Programs that are using risk-based inspection programs by 50% as measured by the Voluntary National Retail Food Regulatory Program Standards.  In FY 2004, there was a 100% increase in inspections. There has been a 33% increase in 2005. 
3. 27.  Voluntary Program Standards: Enrolled 185 jurisdictions in the Voluntary Program Standards.  This meets our goal of enrolling 180 in FY 2005.
4. 28.  2003 Survey of Foodborne Illness Risk Factors in (retail-level) Food Establishments: Released the report of the results of the 2003 data collection of foodborne illness risk factors in retail-level food establishments on September 14, 2004 via FDA/CFSAN web posting.  Q&A's related to the report were also developed and made available in January 2005 and serve to provide the reader with a better understanding of the report and its contents. 

   FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004)

5. 29.  WTO Cooperative Program Commitments: Developed a strategy to help engage stakeholders in meeting World Trade Organization (WTO) commitments that affect the FDA's Cooperative Programs' regulatory infrastructure.  A plan outlining how FDA will be inclusive and transparent in proceeding to determine equivalency, has been agreed to by all FDA components, the European Union (EU) and other stakeholders.  Grade "A" milk and milk products have been identified as an area requiring an immediate need.

Chemical Contaminants, Pesticides and Other Hazards

1. 30.  Survey of Foods for Perchlorate:  In February 2005, in conjunction with FDA's Office of Regulatory Affairs (ORA), issued an expanded survey assignment to determine perchlorate levels in 450 samples of various domestic and imported foods.  The first phase of the assignment called for collection and analysis of 240 food samples that include fresh fruits and vegetables, fruit juices, and grain products.  The second phase of the assignment called for collection and analysis of additional samples of fresh fruits and vegetables, fruit juices, and grain products and seafood.

   FDA Collection and Analysis of Food for Perchlorate

2. 31.  Perchlorate in Foods: In 2005, expanded application of methods for perchlorate analysis to additional high priority foods (e.g., grain products, fruit juices, fish fillets) requested for collection in the FDA 2005 perchlorate field assignments.

   Rapid Determination of Perchlorate Anion in Foods by Ion Chromatography- Tandem Mass Spectrometry

3. 32.  Report to Congress – Perchlorate Survey: Completed Perchlorate Report 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.  The report was completed and submitted for submission to Congress. 
4. 33.  Proposed Rule for Arsenic in Bottled Water: On December 2, 2004, published in the Federal Register (69 FR 70082) a proposed rule to amend FDA's bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic.  This notice proposes to ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards. 

   Federal Register (69 FR 70082)

5. 34.  Final Rule for Arsenic in Bottled Water: On June 9, 2005, published in the Federal Register (70 FR 33694) 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. 

   Federal Register (70 FR 33694)

6. 35.  Furan Action Plan: On September 1, 2005, 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.

   FDA Action Plan for Furan in Food

7. 36.  Furan in Food: In June 2005, 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. 

   Exploratory Data on Furan in Food

8. 37.  Final Generic "Channels of Trade" Guidance: On May 18 2005, published in the Federal Register (70 FR 28544) 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.

   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

9. 38.  Foodborne Chemicals Workshop: On May 2-6, 2005, co-sponsored, in conjunction with JIFSAN, a workshop, in Annapolis, Maryland, on methodologies for assessing and estimating exposure of food-borne chemicals.  The workshop was convened to update the principles and practices of exposure assessment for chemicals in food.   The end product of the workshop was a draft report that will undergo further revisions and then publish under the auspices of the WHO/FAO.
10. 39.  Acrylamide in Food: In June 2005, 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. 

    Exploratory Data on Acrylamide in Food

11. 40.  Dioxin Analysis Results/Exposure Estimates: In June 2005, 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. 

    Dioxin Analysis Results/Exposure Estimates

Transmissible Spongiform Encephalopathies

1. 41.  BSE: On September 7, 2005, 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" (69 FR 42256). Among other things FDA 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.

   Federal Register (70 FR 53063) (Interim Final Rule amendments)

2. 42.  BSE Risk Assessment: Through a contract with the Institute of Food Technologists, the Harvard Center for Risk Analysis modified their 2003 bovine spongiform encephalopathy (BSE) risk assessment model to incorporate a separate slaughterhouse module and to model response rate as a function of dose and time.  The updated BSE risk assessment model can now be used to assess more accurately the risk from BSE associated with FDA-regulated food and cosmetics, this will be particularly useful in BSE-related regulatory actions.

   An Evaluation of the Risk of Variant Creutzfeldt-Jakob Disease from Exposure to Cattle-Derived Protein Used in Cosmetics

Game Meat

1. 43.  Game Meat: Identified manufacturers or processors of game meats and game meat products and a field assignment was drafted in preparation for issuance in FY 2006.

Food Allergens

1. 44.  FALCPA Implementation: Fully completed numerous accomplishments in the implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).  Workgroups to develop processes, designate liaisons and to draft guidance for implementing the provisions were established.  CFSAN conducted orientation sessions on FALCPA.   Throughout FY 2005, CFSAN held approximately 20 meetings about FALCPA with groups representing consumers, state and local regulators, and various food industries.
2. 45.  Food Allergens Public Meeting:  On August 19, 2005, at the Harvey Wiley Building, College Park, MD, held a public meeting to obtain expert comment and consultation from stakeholders to help the Agency to define and permit the voluntary use on food labeling of the term "gluten-free".  The meeting focused on foods manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food.

   Meeting Transcript

3. 46.  Gluten-free Labeling: In response to FALCPA, completed a draft proposed rule on gluten-free labeling.  The proposed rule is currently undergoing FDA clearance with the goal that it will publish in FY 2006.
4. 47.  Food Allergens Guidance: On October 5, 2005, issued guidance for industry entitled: "Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004." This is the first edition of a guidance document that contains questions and answers relating to food allergens, including questions and answers about the Food Allergen Labeling and Consumer Protection Act. On December 14, 2005, FDA/CFSAN issued the 2nd edition which is a revision of the first edition that responds to additional questions received after issuance of the 1st edition. FDA expects to issue subsequent editions of this guidance document by adding new questions and answers to the guidance; new questions and answers will be identified by the date that they are added to the guidance. 

   Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)

5. 48.  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.
6. 49.  Egg and Milk Test Kits: Completed evaluation studies for multiple test kits for the detection of egg and milk in food commodities and presented these studies at several scientific meetings. Validation protocols following AOAC harmonized/Performance Tested guidelines have been prepared and the validation studies involving AOAC, Health Canada, and FDA are proceeding.  FDA/CFSAN will coordinate and direct the egg test kit validation study and Canada will coordinate and direct the milk test kit study.
7. 50.  Peanuts in Foods: Published a Laboratory Information Bulletin (LIB #4341), "Application of Validated, Multiple Laboratory/Performance Tested Methods for the Detection of Peanuts in Foods" Vol.21. (2) 2005 instead of a CPG for the use of validated test kits. The validation study was published in a peer-reviewed journal, Park et al., 2005. Performance Tested Multiple Validation Study of ELISA Based Assays for the Detection of Peanuts in Food in the Journal of AOAC International (Jan/Feb). 88, 156-160.  A table outlining sample sizes with application to food products has been forwarded to FDA's Office of Regulatory Affairs (ORA) for inclusion in the Agency's Investigations Operations Manual.
8. 51.  Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food: On June 17, 2005, announced in the Federal Register (70 FR 35258) the availability of a draft report entitled: "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food."  The draft report, prepared by an interdisciplinary group of scientists from CFSAN,  was prepared to facilitate the further development of CFSAN's policy for food allergens, including the Center's implementation of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

   Federal Register (70 FR 35258)
   Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food

Dairy Safety

1. 52.  Federal Imported Milk Act CPG: On April 13, 2005, announced in the Federal Register (70 FR 19489) the availability of a compliance policy guide entitled:  "Sec. 560.400 – Imported Milk and Cream – Federal Import Milk Act (CPG 7119.05)."  The CPG provides guidance on the applicability of the Federal Import Milk Act (FIMA) to imported milk and cream. 

   Guidance for FDA Staff Sec. 560.400 - Imported Milk and Cream – Federal Import Milk Act (CPG 7119.05)

Education

1. 53.  Consolidation of CFSAN's Consumer and Outreach Activities: On January 14, 2005, announced the formation of the new Office of Food Safety, Defense, and Outreach (OFSDO), which consolidated all of the Center's outreach and education activities.  OFSDO now serves as the overall Center lead responsible for coordinating, developing, and delivering high-quality outreach and education products to our stakeholders (e.g., consumers, industry, health professionals, and other regulatory authorities).  This organizational change is designed to improve the quality, quantity, and timeliness of CFSAN outreach and education. 

   CFSAN announced the formation of the new Office of Food Safety, Defense, and Outreach (OFSDO)

2. 54.  Safe Handling of Produce:  In September 2005, 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.
3. 55.  "Moms to Be" Educational Program:  In August 2005, launched the "Food Safety for Moms-to-Be" public health education campaign.  This broad education campaign in English features a new comprehensive website and an educator's kit for healthcare professionals designed to educate pregnant and soon-to-be pregnant women about food safety.  Topics discussed include the risks of Listeria monocytogenes, Methylmercury and Toxoplasma.

   Food Safety for Moms-To-Be

4. 56.  "Moms to Be" Educational Program:  In August 2005, launched the "Food Safety for Moms-to-Be" public health education campaign.  This broad education campaign in Spanish features a new comprehensive website and an educator's kit for healthcare professionals designed to educate pregnant and soon-to-be pregnant women about food safety.  Topics discussed include the risks of Listeria monocytogenes, Methylmercury and Toxoplasma.

   Seguridad alimentaria para futuras mamás

5. 57.  Listeria Education Program: In FY2005, 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.

---

Part II: Improving Nutrition and Dietary Supplement Safety

Nutrition Health Claims and Labeling

1. 58.  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 periodically and shared with appropriate CFSAN staff and FDA senior management.
2. 59.  Keystone Forum:  Participated, along with representatives of academia, industry and government, in the first plenary session of the "Keystone Forum on Away-From Home Foods: Opportunities for Preventing Weight Gain and Obesity" on April 26-27, 2005, and July 21-22, 2005, in Washington, D.C.   The first 2-day forum session focused on building a shared understanding of the market and nutritional aspects of away-from-home foods, as well as opportunities to begin to identify potential avenues for action.  The second forum session focused on aspects of consumer behavior, consumer-oriented nutrition information, nutrition education, and marketing communication (commercial and social).
3. 60.  "Healthy": On September 29, 2005, announced in the Federal Register (70 FR 56828) and 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, "first-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. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has 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. The agency has also 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.

   Federal Register (70 FR 56828)

4. 61.  Prominence of Calories: On April 4, 2005, published in the Federal Register (70 FR 17008) an advance notice of proposed rulemaking (ANPRM) entitled: "Food Labeling: Prominence of Calories."  The purpose of the ANPRM is to request comment on whether to amend certain provisions of the Agency's nutrition labeling regulations to give more prominence to calories on food labels.   The ANPRM was issued in response to recommendations of the Obesity Working Group 1 (OWG 1), which was created by the Commissioner of Food and Drugs to develop an action plan to address the Nation's obesity problems. 

   Federal Register (70 17008)

5. 62.  Serving Size: On April 4, 2005, published in the Federal Resister (70 FR 17010)  an advance notice of proposed rulemaking (ANPRM) entitled: "Food Labeling: Serving Sizes of Products that can Reasonably be Consumed At One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes."  The purpose of the ANPRM is to request comment on whether to amend certain provisions of the Agency's nutrition labeling regulations concerning serving size.  FDA is issuing this ANPRM in response to recommendations of the Obesity Working Group 1 (OWG 1), which was created by the Commissioner of FDA to develop an action plan to address the Nation's obesity problem.

   Federal Register (70 FR 17010)

6. 63.  Dietary Guidelines: Participated in the review and dissemination of public information on the "2005 Dietary Guidelines for Americans."

Dietary Supplements

1. 64.  Premarket Notification Program for New Dietary Ingredients – Public Meeting: On November 15, 2004, held a public meeting about the premarket notification program for New Dietary Ingredients (NDIs).  FDA solicited comments from industry, consumers, and other interested members of the public concerning the content and format requirements for NDI notifications made under the Federal Food, Drug, and Cosmetic Act (the Act).
2. 65.  Dietary Supplements: Strategy for the Further Implementation and Enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA):  On November 9, 2004, announced in the Federal Register (69 FR 64957) the availability of 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.
3. 66.  Dietary Supplement Labeling Guide:  In April 2005, 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. 

   Dietary Supplement Labeling Guide

---

Part III: Ensuring Cosmetic Safety

Cosmetics

1. 67.  Alpha Hydroxy Acids Guidance:  On January 10, 2005, announced in the Federal Register (70 FR 1721) the availability of a guidance document entitled: "Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients."  The guidance recommends content for a labeling statement for cosmetic products containing alpha hydroxy acids (AHAs) as ingredients.  This action was prompted by a citizen petition filed by the Cosmetic, Toiletry, and Fragrance Association, which requested that FDA issue a regulation establishing labeling requirements relating to sun protection with use of cosmetic products containing AHAs. 

   Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients

---

Part IV: Ensuring Food Safety:
Crosscutting Areas

Science Base

1. 68.  Core Competencies Pilot: Piloted the development of Core Competencies with two CFSAN offices: the Office of Food Additive Safety and the Office of Science.  The process will serve as a template for developing the core competencies with other CFSAN offices.   This process is consistent with the DHHS Competency-Based approaches and will permit CFSAN to move ahead with developing core competencies for mission-critical positions, such as scientists and consumer safety officers.
2. 69.  Social Science Research on Connections between Food Labeling and Weight Management:  In April 2005, prepared a summary that reports weighted frequencies based on the FY 2004 Health and Diet Survey (HDS) Supplement that assessed consumer's knowledge and understanding of carbohydrates, diets based on limiting carbohydrates, and carbohydrate claims in the marketplace (e.g., net carbs). 
3. 70.  Food Safety Intervention Strategy:  In implementing a food safety intervention strategy to track progress toward the attainment of the public health food safety goals, private/public sector capacity-building coalitions were given responsibility to devise developmental plans and timelines to strengthen Competent Authority (CA) capability and to affect performance improvements in the overall Low-Acid Canned Foods/Acidified Foods (LACF/AF) industry.  Objectives were identified and timelines for completion and implementation of goals were developed by coalition workgroups.  The five coalition workgroups included (1) regulations and enforcement; (2) inspections; (3) communications; (4) capacity-building; and (5) laboratory development.  The workgroups cooperatively will implement goals and objectives within the defined timeframe.  The local CA (i.e., Digesa in the Republic of Peru) will inspect 100% of the LACF/AF industry in their country over the next 1-2 year period.  Validation inspections will be performed by FDA/CA teams ever 1-2 years henceforth.  Improvements and accomplishments will be quantified by means of a measure-act-measure approach.
4. 71.  Adverse Events Studies: In conjunction with the CFSAN Adverse Events Reporting System (CAERS), collected and completed the analysis of adverse event data from the Slone Epidemiology Survey, the Behavioral Risk Factor Study and the National Emergency Injury Surveillance Study.  The results of the analysis have been transmitted to the applicable CFSAN program office.
5. 72.  Adverse Event Data Management at FDA: On June 18, 2005, implemented cross-center training program for new hires using a clinical and epidemiology training module based on real adverse event data analyses from FDA.  Participants comprised staff from all FDA centers. 
6. 73.  Consumer Knowledge of Trans fats, Saturated fats and Omega-3 fats:  In an effort to inform consumers about how much trans fat, saturated fats and Omega-3 fats are in the foods that we eat and the risk posed by eating too much of these fats and acids,  FDA/CFSAN has begun an effort to increase consumer knowledge by 40% for trans fat, by 10% for saturated fat, and by 10% for omega-3 fatty acids based on the completion of the FY 2004 and FY 2007 Health and Diet Survey (HDS).  During FY 2005, CFSAN 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.

International

1. 74.  SPS Agreement: In FY 2005, coordinated FDA scientific and technical review of 98 proposed foreign Sanitary and Phytosanitary (SPS) measures relating to FDA's food and feed safety jurisdictional areas that were notified by Member Countries to World Trade Organization (WTO) under the SPS Agreement.  CFSAN drafted U.S. comments on 40 of these notifications, i.e., those that warranted comment (as of 4/29/05).  The comments were subjected to interagency collaboration and sent to the U.S. Enquiry Point for submission to the appropriate foreign government.  CFSAN anticipates an additional 75 notifications to be reviewed with comments by the end of FY 2005.
2. 75.  AFDO Working Group Activity: In accordance with the Association of Food and Drug Officials' (AFDO) charge for 2004-2005, chaired a working group composed of industry, states and federal agencies and:
   • Published a harmonized model system for state food export certificates;
   • Encouraged at least 80% of the states to develop export certificate websites and capture the updated links on the website;
   • Tested the harmonized state export certificates for acceptability by other country governments;
   • Requested information on export certificate requirements of importing  countries through a new Food and Agricultural Import Regulations and Standards (FAIRS) Report from USDA-FAS posts abroad, to be posted and updated annually on the website beginning September 2005; and
   • Completed work to enable U.S. export certificate website to go "live."
3. 76.  International Technical Assistance Activities: Collaborated with USDA to develop a combined database ("metadatabase") to include all U.S. federal international technical assistance activities.  CFSAN created a vehicle to make this information more accessible to diverse federal agencies participating in SPS-related technical assistance, through a new feature "Technical Assistance/Trade Capacity Building Issues" in the SPS/TBT Weekly News.

Internal Processes

1. 77.  CFSAN Regulations Writing Consolidation:  Implemented several changes toward the consolidation of its regulations writing function within the Center.  In late FY 2004, the responsibility of the regulation writing function and managing of the CFSAN process for planning, developing, and clearing regulations was delegated to CFSAN's Office of Regulation and Policy (ORP).  In FY 2005, in an effort to promote efficiency and effectiveness in the regulations development operations, CFSAN's Economics Team and its Consumer Studies Team formerly located in CFSAN's Office of Scientific Analysis and Support were moved to ORP.  These two staffs report to a newly created position of Associate Director for Social Sciences within ORP.   Realignment of the Economics Team and the Consumer Studies Team to ORP, as well as creation of the new Associate Director for Social Sciences is not only another step toward streamlining Center operations, it also will enhance the Center's ability to complete high quality rulemakings in a timely fashion.  In subsequent years, CFSAN will perform a review to determine if the Center has improved this function.
2. 78.  LACF/AF Outreach Program: Conducted a training program on LACF/AF inspections in South America.  The program initially involved planning and performing a meaningful number of cooperative inspections with FDA counterpart agencies to assess the overall national LACF/AF industry and Competent Authority performance.  Based upon analysis of the overall inspection findings, the LACF Team (1) developed and implemented "on-site' outreach training programs to address specific shortcomings and deficiencies and (2) established private/public sector capacity-building coalitions to carry forward the missions and objective of the program.
3. 79.  Program Evaluation Procedures: On August 10, 2005, issued the CFSAN Program Evaluations Model.  The model provides guidance to CFSAN staff for evaluating program areas and provides a mechanism for CFSAN management to incorporate science-based risk management into the Compliance Program process.  During FY 2005, CFSAN evaluated six program areas, usin the model as a guide: Domestic and Import Seafood HACCP; Juice HACCP Inspection Program; Domestic and Imported Cheese and Cheese Products; Infant Formula; Domestic Cosmetics; and Food and Color Additives.

Focused Economic-based Regulations

1. 80.  FDA/FSIS Standards of Identity (General Principles): On May 20, 2005, published in the Federal Register (70 FR 29214) a proposed rule entitled: "Food Standards; General Principles and Food Standards."  This is a joint proposal between the Food Safety and Inspection Service (FSIS) under the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA).  The FDA and FSIS are proposing to establish a set of general principles for food standards. The proposed general principles will establish the criteria that the agencies will use in considering whether a petition to establish, revise, or eliminate a food standard will be the basis for a proposed rule.  In addition, each agency may propose to establish, revise, or eliminate a food standard on its own initiative or may propose revisions to a food standard in addition to those a petitioner has requested. These proposed general principles are the agencies' first step in instituting a process to modernize its standards of identity (and any accompanying standards of quality and fill of container) and standards of composition.

   Federal Register (70 FR 29214)

2. 81.  Fluid Ultra-Filtered Milk: On October 19, 2005, published in the Federal Register (70 FR 60751) proposed rule to amend its regulations to provide for the use of fluid ultrafiltered milk (UF) in the manufacture of standardized cheeses and related cheese products.  This action responds principally to two citizen petitions: One submitted by the American Dairy Products Institute and another submitted jointly by the National Cheese Institute, the Grocery Manufacturers of America, Inc. and the National Food Processors Association. FDA tentatively concludes that this action will promote honesty and fair dealing in the interest of consumers and, to the extent practicable, will achieve consistency with existing international standards of identity for cheeses and related cheese products.

   Federal Register (70 60751)

3. 82.  Parmesan Cheese and Frozen Desserts:  On September 27, 2005, announced in the Federal Register (70 FR 56409) advance notice of proposed rulemaking entitled: ‘Frozen Desserts; Petition to Revoke Standards for Goat's Milk Ice Cream and Mellorine and to Amend Standards for Ice Cream and Frozen Custard, Sherbet, and Water Ices, Petition to Amend Standard for Parmesan and Reggiano Cheese." The Food and Drug Administration (FDA) is announcing that the following two petitions have been filed:  A petition requesting that the agency revoke the standards of identity for goat's milk ice cream and mellorine, and amend the standards of identity for ice cream and frozen custard, sherbet, and water ices in numerous respects; and a petition requesting that the agency amend the standard of identity for parmesan and reggiano cheese to decrease the minimum curing time from 10 months to 6 months. The FDA is issuing an advance notice of proposed rulemaking (ANPRM) to request comments to determine whether the action proposed in the petitions would promote honesty and fair dealing in the interest of consumers.

   Federal Register (70 FR 56409)

Management Initiatives

1. 83.  Zero-based Budget Process (ZBB): Implemented for the first year a process where CFSAN relied on zero based budgeting to ensure that financial resources required to meet the Center's needs are allocated in an economic and efficient manner.  The result of this process was much additional savings with reduced funding.  We were able to limit each Office to 75% of their previous funding levels and the Offices managed to allocate their funds to meet their needs.  The biggest change we accomplished by adopting ZBB was that we were able to identify program areas within each Office and make funding recommendations based on program needs. 
2. 84.  Decommissioning Federal Building 8 (FB-8): Completed the chemical and radioactive decommissioning of FB-8. CFSAN has submitted the final report, called the Final Status Survey, to the Nuclear Regulatory Commission (NRC).  On June 6, 2005, the NRC officially released the FB-8 facility for unrestricted use.  CFSAN has completed all of its obligations to the FB-8 decommissioning project.
3. 85.  CFSAN's Adjunct Building: University Station: Completed construction and occupancy of a second building called "University Station," located next door to the Harvey Wiley Building.  This marks the end of a significant milestone in the relocation of nearly all CFSAN headquarters staff to a single location.  The building is fully furnished and all laboratories are operational.
4. 86.  A-76 Training: Conducted a training assessment to determine the training needs for all CFSAN clerical/support staff affected by OMB Circular No. A-76.  This Circular sets forth the procedures for determining whether commercial activities should be performed under contract with commercial sources or in-house using Government facilities and personnel. To prepare them for changes in work functions in response to this circular, the CFSAN Staff College offered to support/clerical staff a series of training courses and workshops in communications and interpersonal skills, computer science and management and budget well as mentoring programs and developmental initiatives to successfully transition these staff into other functions within CFSAN.  Over 180 CFSAN staff enrolled in these sessions.
5. 87.  1^st Year Phase of the CFSAN Leadership Legacy Initiative: In FY 2005, initiated the application process for two leadership development opportunities targeted for career/career conditional, full-time CFSAN employees who have demonstrated leadership potential and who are currently in non-supervisory positions.  The first opportunity will be for selected employees to perform a one-year detail with the Office of the Center Director on the Executive Operations Staff (EOS).  The second opportunity will be for selected employees to participate in CFSAN's newly established "Leaders Developing Leaders (LDL) Program.  The launch of these two opportunities represents a key step in shifting to a more intentional, systematic and Center-focused approach to the development of CFSAN's future leaders.