CFSAN FY 2007 Report to Stakeholders

FY 2007 Program Priorities
FY 2006 Program Priority Accomplishments
FY 2006 Other Significant Accomplishments

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FY 2007 Program Priorities

Table of Contents

1. I. Food Defense

   • Regulations and Guidance
   • Research
   • Preventive Measures

2. II. Food Safety

   • General
   • Chemical Contaminants, Pesticides and Other Hazards
   • Cooperative Programs
   • Dairy Products
   • Education/Outreach
   • Egg Safety
   • Food Additives
   • Food Allergens
   • International
   • Listeria
   • Pandemic Flu
   • Produce Safety
   • Research
   • Seafood Safety
   • Transmissible Spongiform Encephalopathies (TSEs)

3. III. Nutrition and Labeling

   • Nutrition/Preventing Obesity
   • Food Labeling
   • Infant Formula

4. IV. Dietary Supplements and Cosmetics

   • Dietary Supplements
   • Cosmetics

5. V. Priority Ongoing Activities

Part I
Food Defense

1.1.1	Complete a final rule for prior notice of imported food shipments.

1.2.1	Refine rapid mass spectrometric methods for the detection of botulinum neurotoxin in foods.
1.2.2	Evaluate Luminex/Bioplex and Electrochemiluminescent Multiplex technologies for multiple bioterrorism-related toxins.
1.2.3	Develop DNA microarray for detection of foodborne viruses.
1.2.4	Evaluate DNA microarray, genome optical mapping and bioinformatics analysis for use in forensic identification of pathogenic Escherichia coli and Shigella species.
1.2.5	Determine synergistic toxicity from the interaction of multiple threat agents, such as a food-related chemical and a food-borne microbial toxin.

1.3.1	Develop a vulnerability assessment of product/ingredient/additive-agent scenarios, including an in-depth review of preventative controls and various processing or engineering technologies to reduce risk of intentional contamination.
1.3.2	Plan a meeting of the Food Safety/Food Defense Task Forces (comprised of 32 States) to raise awareness, discuss food defense strategies, and ensure food defense preparedness.
1.3.3	Conduct at least four CARVER vulnerability assessments in cooperation with industry and states through the Strategic Partnership Program on Agroterrorism.
1.3.4	Complete the CARVER + Shock software screening tool to assist industry and states in conducting vulnerability assessments using the CARVER + Shock approach.
1.3.5	In conjunction with ORA, conduct a multi-agency Food Defense Surveillance Assignment in collaboration with states to raise awareness, enhance communication, and ensure food defense preparedness.
1.3.6	Conduct food bioterrorism preparedness study.
1.3.7	Initiate development of a manual of options for vulnerability mitigation strategies for food production steps.
1.3.8	Enhance the food defense training program by expanding coverage of chemical, radiological, and priority microbiological agents not previously covered.
1.3.9	Prepare and provide traditional and web-based training on the ALERT food defense awareness program, targeted at FDA investigators, state and local regulators and industry operators, reaching greater than 90 percent of FDA field staff.

Part II
Food Safety

2.0.1	In conjunction with ORA, implement pilot data mining program to identify and inspect up to 10 importers bringing in large quantities of high risk foods into the U.S.
2.0.2	In conjunction with CDC and NIH, develop statistical methods to study the effects of food consumption patterns on high-incidence diseases such as diabetes and obesity.
2.0.3	Provide to Center microbiologists new statistical methodologies for evaluating microbiological screening methods.

2.1.1	Publish final guidance for lead levels in candy
2.1.2	Publish draft updated pesticides compliance policy guide.

2.2.1	Publish 2007 Supplement to the 2005 Food Code.
2.2.2	Increase number of enrollees in Retail Food Program Standards to 240.
2.2.3	Ensure that at least 26% of enrollees in Retail Food Program Standards meet two or more Standards.

2.3.1	Complete revised draft "Pathogens in Dairy Products" compliance policy guide.
2.3.2	In conjunction with ORA, finalize and implement the raw milk cheese Action Plan for high risk cheese products.
2.3.3	Complete a proposed rule to amend the standards of identity for yogurt.

2.4.1	Develop and disseminate training materials for teachers on the food label.
2.4.2	Launch nutrition label media campaign for children/adolescents.

2.5.1	Complete egg safety final rule.

2.6.1	Develop draft guidance on electronic submissions for food ingredient review.
2.6.2	Update chemistry guidance for indirect food additives.
2.6.3	Publish additional updated Redbook chapters on the Internet.
2.6.4	Hold a public meeting to solicit input from stakeholders in addressing issues concerning the regulatory status and labeling of salt.

2.7.1	Develop Federal Register notice to solicit comments from stakeholders on current trends in the use of advisory labeling regarding food allergens.
2.7.2	Publish a proposed rule for gluten-free labeling in response to FALCPA.
2.7.3	Validate egg allergen detection test kits in collaboration with Health Canada, EU, the Food Allergy Research and Resource Program, and industry, using FDA-approved protocols.

2.8.1	Provide technical support to FAO/WHO in the development of improved techniques for linking microbiological criteria to public health outcomes.
2.8.2	Security and Prosperity Partnership (U.S., Mexico, and Canada): Participate in appropriate meetings domestically and internationally to accomplish those deliverables related to food safety in the food and agriculture agendae.
2.8.3	Codex Committees and Working Groups: Participate in the development of Codex standards, including: representing U.S. and FDA at Codex committee/task force sessions and working groups; developing Codex working drafts as appropriate; developing comments and positions on Codex standards and related issues; and participating in U.S. Codex policy and strategic planning activities. FY 2007 Codex Committees/Task Forces sessions to be attended are: Commission Session: Codex Alimentarius Commission Cross-Cutting General Subject Committees: General Principles Food Additives Contaminants Food Import and Export Inspection and Certification Systems Nutrition and Foods for Special Dietary Uses Food Labeling Food Hygiene Methods of Analysis and Sampling Pesticide Residues Foods Derived from Biotechnology Antimicrobial Resistance Quick Frozen Foods Regional Coordinating Committees: North American and Southwest Pacific Commodity Committees: Processed Fruits and Vegetables Fats and Oils

2.9.1	Complete draft Compliance Policy Guide on L. monocytogenes in ready-to-eat (RTE) foods.
2.9.2	Complete draft Listeria/smoked finfish risk assessment.
2.9.3	Complete draft guidance on the control of L. monocytogenes in RTE foods.
2.9.4	Respond to a citizen petition (Docket No. 2003P-0574) to establish a regulatory limit of 100 colony forming units per gram for Listeria monocytogenes in foods that do not support the growth of the microorganism.

2.10.1	Conduct risk communication research to help preparedness and response to a possible pandemic outbreak.
2.10.2	Initiate new research to detect and identify viruses that are known to cause outbreaks of foodborne infections, such as Hepatitis A.
2.10.3	Evaluate levels of viable and polymerase chain reaction-detectable viruses and water quality indicators in shellfish and shellfish harvest waters.
2.10.4	Develop micro-chip surface chemistries to expand the size range of analytes that can be detected in foods by Surface Plasmon Resonance (SPR); conduct a multi-laboratory validation study to evaluate the robustness of SPR technology.
2.10.5	In conjunction with USDA, develop a food safety risk assessment on the public health impact of highly pathogenic avian influenza virus in poultry meat, shell eggs, and processed eggs.

2.11.1	Publish draft final guidance for fresh cut produce.
2.11.2	In cooperation with the California Department of Health Services and Department of Food and Agriculture, continue the Lettuce and Leafy Green Safety Initiative which will include an assessment of practices at farms, fresh-cut processing facilities and packaging facilities; continued outreach with industry to facilitate/promote research on leafy greens safety; and collaboration with federal, state and local public health officials in disease detection and outbreak response.
2.11.3	Hold public meeting(s) regarding produce safety.
2.11.4	Issue draft guidance for processors of low acid juice on prevention of botulinum toxin formation.

2.12.1	Develop an analytical method for detection, confirmation and quantification of benzene in beverages and selected foods.
2.12.2	Develop analytical methods for analysis of low levels of trans fatty acids in foods.
2.12.3	Complete methods to isolate and purify major components in two dietary supplements of safety concern, blue cohosh and teucrium.

2.13.1	Publish the Fourth Edition of the Fish and Fishery Products Hazards and Controls Guidance.
2.13.2	Work with other countries to control the hazard of unapproved drugs in aquacultured seafood.
2.13.3	Submit for publication results of studies on formation of scombrotoxin in tuna.
2.13.4	Work with the National Marine Fishery Service (NMFS) to revise existing memorandum of understanding between the agencies.
2.13.5	Participate in pilot of JIFSAN Good Aquaculture Practices training in Asia.
2.13.6	Evaluate risks from methylmercury in seafood and benefits from eating seafood.
2.13.7	Develop statistical sampling plans for post harvest processes of oysters.

2.14.1	Complete risk assessment to determine potential of Chronic Wasting disease in infected cervids as a human health risk.
2.14.2	Publish final rule on Bovine Spongiform Encephalopathy (BSE) recordkeeping.
2.14.3	Complete final BSE rule on prohibited cattle materials.

Part III
Nutrition and Labeling

3.1.1	Publish guidance on the evidence-based scientific review system for health claims (including qualified health claims).
3.1.2	Hold a public meeting on foods that companies are marketing as "functional foods."
3.1.3	In collaboration with NIH, analyze dietary intake of fish in pregnant vs. non-pregnant women.
3.1.4	Determine percent of American consumers aware of U.S. Dietary Guidelines for Americans 2005.

3.2.1	Publish an ANPRM to solicit comments on updating daily values in nutrition labeling.
3.2.2	Publish a proposed rule to revise, as appropriate, existing regulation that requires irradiated food to be labeled.
3.2.3	Publish a final rule on in-lid labeling for shell eggs.
3.2.4	Develop proposed rule to implement FDAMA notifications for nutrient content claims and health claims.

3.3.1	Complete final rule for infant formula Good Manufacturing Practices (cGMPs) and quality factors.
3.3.2	Establish a database of phenotypic array data for Enterobacter sakazakii strains.

Part IV
Dietary Supplements and Cosmetics

4.1.1	Publish a final rule for dietary supplement current Good Manufacturing Practice requirements (cGMPs).
4.1.2	Publish final rule on "per day" labeling for dietary supplements.
4.1.3	Develop (1) a proposed rule to amend 21 CFR 190.6 to clarify information that must be included in a New Dietary Ingredient (NDI) Notification; and (2) a draft guidance with recommendations on the kind of scientific information the Center would find useful in NDI notifications.

4.2.1	Increase by 400 the number of formulations filed in the Voluntary Cosmetic Registration Program.
4.2.2	Distribute information about health hazards associated with tattoo inks, especially permanent make-up inks.

Part V
Priority Ongoing Activities

Food Defense

1. 1.  Improve quality and management of Bioterrorism/Food Registration database
2. 2.  Conduct interagency microbial forensics research efforts with the Department of Homeland Security.
3. 3.  Support the Food Emergency Response Network (FERN) and enhance the interface between FDA and the Nationwide Laboratory Response Network (LRN) and utilize e-Lexnet for data exchange.
4. 4.  Participate in emergency response exercises.

Food Safety

General

1. 5.  Continue development of a proposed rule to modernize the food cGMP requirements.
2. 6.  Utilize CDC PulseNet in outbreak investigations.
3. 7.  In conjunction with ORA, conduct 5600 domestic and 100 foreign inspections of high risk firms.
4. 8.  In conjunction with ORA, perform 71,000 import field exams and conduct sample analyses on products with suspect histories.
5. 9.  In conjunction with ORA, complete the evaluation and classification of foreign firm inspections.
6. 10.  Better identify high-risk compliance issues.
7. 11.  Effectively identify, extract, and summarize compliance data.
8. 12.  Promote information exchange on outbreak investigation outcomes.
9. 13.  Between 2001 and 2010, increase by 10% the percentage of American consumers following key food safety practices, based on the total population of adults who engaged in the practice.

Food and Color Additives

1. 14.  Review Food and Color Additive Petitions within the statutory timeframe.
2. 15.  Review Food Contact Notifications within the statutory timeframe.
3. 16.  Review GRAS notices within the established timeframe.
4. 17.  Review Biotechnology Notices within the established timeframe.
5. 18.  Review New Protein Consultations within established timeframe.
6. 19.  Maximize ability to accept electronic industry submissions by upgrading FARM electronic document management and other database systems.
7. 20.  Continue efforts aimed at reducing the median FDA time to approval or tentative approval of food and color additive petitions.

Food Allergens

1. 21.  Review labeling exemption notifications and petitions in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and its mandated timeline.
2. 22.  In conjunction with ORA, target enforcement of allergen labeling violations.
3. 23.  In conjunction with ORA, issue and complete a field assignment to evaluate compliance with the FALCPA of imported foods as well as foods produced by small and mid-size manufacturers and processors.
4. 24.  Between 2001 and 2010, reduce by 19% the number severe allergic reactions to food among American adults.

Bioengineered Foods

1. 25.  Serve as technical expert and U.S. lead for Codex Biotech Task Force.
2. 26.  Serve as head of U.S. delegation and technical expert for OECD Task Force on the Safety of Novel Foods and Feeds.
3. 27.  Provide technical assistance to USG on food biotechnology issues.
4. 28.  Develop and maintain consistency of FDA's food biotechnology policy by interactions within the Center, FDA, U.S. Government and the international community on issues related to food biotechnology and education of foreign counterparts.

Chemical Contaminants, Pesticides and Other Hazards

1. 29.  In conjunction with ORA, collect and analyze 8,000 food samples for pesticides and chemical contaminants.
2. 30.  In conjunction with ORA, collect and analyze samples of seafood and honey for the presence of chloramphenicol.
3. 31.  In conjunction with ORA and FDA's Center for Veterinary Medicine (CVM), analyze human foods and animal feeds for dioxins to refine exposure assessment and identify opportunities to reduce exposure.
4. 32.  In conjunction with ORA, analyze additional commodities such as grains, meals, apples and juices for the presence of perchlorate.

Cooperative Programs

1. 33.  Continue to work with States, Territories, Local Agencies and Tribal Nations to promote the adoption of the 2005 Food Code, with an emphasis on those that are engaged in Food Code adoption rulemaking.
2. 34.  Provide technical support to EPA in its Aircraft Water rulemaking to ensure consistency with FDA requirements under the Interstate Travel Conveyances Program.

International

1. 35.  Represent FDA in U.S. delegations to committees involved in implementing and interpreting existing trade agreements on sanitary and phytosanitary measures (e.g., World Trade Organization (WTO), Sanitary and Phytosanitary (SPS) Agreement, the Central American Free Trade Agreement (CAFTA), and U.S./Chile SPS Agreement).
2. 36.  Represent FDA in multilateral and bilateral negotiations on the SPS sections of trade agreements (e.g., Andean countries, Thailand).
3. 37.  Continue to evaluate the equivalence of the European Union dairy safety system pursuant to our WTO/SPS international and domestic public health commitments to the National Conference on Interstate Milk Shipments (NCIMS).
4. 38.  Assist US trade agencies (e.g., USTR, FAS, State) in negotiating and implementing SPS measures and meet U.S. obligations under the WTO SPS Agreement to assure safety of the U.S. food supply.
5. 39.  Coordinate and leverage CFSAN international technical assistance with GAPs, LACF and aquaculture programs run by JIFSAN to fulfill SPS training obligations of WTO & FTAs. Provide analysis of technical assistance data, answer foreign inquiries and administer International Visitors Program.

Produce Safety

1. 40.  Continue to engage State Departments of Health and Agriculture to minimize the incidence of foodborne illness associated with consumption of fresh and fresh-cut tomatoes and provide technical assistance to industry as needed for enhancement/implementation of its commodity-specific GAP's/GMP's for fresh tomatoes.
2. 41.  Continue collaboration with Mexico in implementing the MOU between FDA and Mexico to address the safety of Mexican cantaloupes imported in the U.S., with emphasis on building confidence in the Mexican risk-based system as it is applied on a national level.
3. 42.  Continue to provide technical assistance to the produce industry as they develop commodity-specific guidance.

Seafood Safety

1. 43.  Complete the collection of samples for a national study on the levels of viral and bacterial pathogens and indicators in U.S. oysters at retail.
2. 44.  Work with the molluscan shellfish industry on control strategies to reduce the risk of Vibrio infections.
3. 45.  Improve existing guidance on proper on-board handling of seafood to the fishing industry that harvest scombroid species, and provide ongoing educational programs for the seafood industry.
4. 46.  Evaluate seafood industry Hazard Assessment Critical Control Point (HACCP) performance.
5. 47.  Develop and maintain seafood case precedent system to capture those unique aspects of cases that amplify or clarify policy regarding hazards or controls.

Education/Training

1. 48.  Following implementation of Center-wide reorganization, ensure that staff is trained for new functions.
2. 49.  Ensure that staff is trained on risk-based approaches and tools.

Nutrition

General

1. 50.  Between 2004 and 2007, increase by 10% the percentage of American consumers who correctly identify that saturated fat increases the risk of heart disease.
2. 51.  Between 2004 and 2007, increase by 10% the percentage of American consumers who correctly identify that omega-3 fat is a possible factor in reducing the risk of heart disease.
3. 52.  Between 2004 and 2007, increase by 40% the percentage of American consumers who correctly identify that trans fat increase the risk of heart disease.
4. 53.  Between 2004 and 2010, increase by 10%, through the development, dissemination and promotion of educational materials, consumer awareness of trans fatty acids, saturated fat and cholesterol.

Food Labeling

1. 54.  Continue the effort to modernize foods standards by developing a final rule on general principles for food standards in conjunction with USDA/FSIS.
2. 55.  Continue to provide technical support and expertise to FDA investigators on all food labeling issues to ensure labels are in compliance with all FDA laws and regulations and conduct enforcement activities related to violative labeling of conventional foods including infant formula and medical foods.
3. 56.  Issue Temporary Marketing Permits (TMP) for the interstate shipment of experimental packs of food varying from requirements of standards of identity, in accordance with 21 CFR 130.17.
4. 57.  Review premarket notifications for small business labeling exemption requests.

Infant Formula

1. 58.  Review premarket notifications for new infant formulas within statutory timeframe.

Health Claims

1. 59.  Review nutrient content/health claim notifications and petitions within applicable timeframes.

Dietary Supplements Safety

1. 60.  Review premarket (75-day) notifications for new dietary ingredients within statutory timeframe.
2. 61.  Review 30-day postmarket notifications for supplement claims in a timely manner.
3. 62.  Identify dietary supplement ingredients/products that raise safety problems, and take appropriate enforcement action.
4. 63.  In conjunction with ORA, take enforcement actions against dietary supplements that contain ephedrine alkaloids (ephedra).
5. 64.  In conjunction with ORA, take enforcement action against unsubstantiated dietary supplement claims (including drug and weight loss claims).

Cosmetic Safety

1. 65.  Analyze all batches of color additives and determine certification status (certify or refuse to certify) within an average of 5 working days.

Crosscutting Areas

Management Initiatives

1. 66.  Conduct supervisory and management training.

Internal Processes

1. 67.  Pilot the development and implementation of Quality Management Systems (QMS) within CFSAN's Division of Enforcement through the Quality Systems Framework and the FDA staff Manual guide for QMS.
2. 68.  Modify CFSAN's Office of Compliance intranet web site as part of the merge into inside.fda.gov and further expand the site to strengthen its usefulness as a primary source of compliance and enforcement information for field and center staff.
3. 69.  Modify the compliance Reference System (precedent files) IT application to be more user friendly and effective tools in food compliance operations.
4. 70.  Between 2004 and 2008, expand CFSAN's Case Management System (CMS) throughout all compliance components within FDA, and develop and implement SOPs for CMS.

Acquisition of Science-based Knowledge

1. 71.  Conduct translational research on analytical methods development and prevention/intervention strategies for contaminants of the food supply in support of FDA's foods regulatory program.
2. 72.  Integrate the current consortia (National Center for Food Safety and Technology, Joint Institute for Food Safety and Applied Nutrition, and National Center for Natural Products Research) and other formal and informal relationships with academic institutions or other scientific organizations with CFSAN's food safety and defense and applied nutrition programs.
3. 73.  Recruit a breadth and depth of pre-eminent scientific expertise for the Food Advisory Committee that will be able to address cutting-edge issues on the forefront of scientists.
4. 74.  Via symposia, reviews, and white papers, initiate the integration of modern biology with nutritional sciences to enhance safety assessment of foods and dietary supplements.

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FY 2006 Program Priority Accomplishments

Final Report - Accomplishments (summary list)
CFSAN FY 2006 Program Priority Accomplishments (detailed list)
Other Significant FY 2006 Accomplishments

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Accomplishments

1. Completed Construction of a BSL3/ABLS3 Laboratory
2. Established a Repository of Curated E.coli O157:H7 Strains and Supporting Database for the Department of Homeland Security
3. Developed DNA Microarray, Genome Optical Mapping, and Bioinformatics Analysis for Forensic Identification of E. coli O157:H7
4. Conducted Nine CARVER (Criticality-Accessibility-Recuperability-Vulnerability-Effect-Reconcilability) + Shock Vulnerability Assessments
5. Published Recycled Plastics Guidance
6. Published Proposed Rule to Require the Declaration of Carmine/Cochineal Extract
7. Published the Revised Report: "Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food"
8. Published Revised Guidance for Industry on Food Allergens and FALCPA
9. Published Guidance for Industry on the Labeling of Certain Uses of Lecithin
10. Published Guidance Concerning the Early Food Safety Evaluation of New Plant Proteins Produced by Bioengineered Plants Intended for Food Use that May be Present in the Food Supply
11. Published Draft Guidance for Lead Levels in Candy
12. Increased Enrollment in the Voluntary National Retail Food Regulatory Program Standards
13. Published and Distributed the 2005 Pasteurized Milk Ordinance
14. Participated in Codex Committees and Related Activities
15. Issued Draft Guidance for Fresh Cut Produce
16. Conducted Consumer Education Campaign on Allergens
17. Co-sponsored Food Safety Conference
18. Published Safe Seafood Handling Brochure
19. Participated in Keystone Initiatives to Address Obesity
20. Developed Educational Material on Healthy Weight Management
21. Implemented Food Labeling Education Campaign
22. Published Final Rule on Voluntary Nutrition Labeling
23. Published Draft Guidance on Whole Grain Labeling
24. Re-opened Comment Period for the Infant Formula Final Rule
25. Developed an Improved Bacteriological Testing Method for Enterobacter sakazakii
26. Distributed Information about the Health Hazards Associated with Tattoo Inks
27. Fully Implemented an Electronic System to Support Participation via Internet in the Voluntary Cosmetic Registration Program
28. Launched Web-based Information System for the Color Certification Program
29. Realigned CFSAN's Office of Management Systems Based on the FY 2005 Workforce Analysis
30. Implemented the CFSAN Leaders Developing Leaders (LDL) Program

CFSAN FY 2006 Program Priority Accomplishments

Food Defense: Research

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Other Significant FY 2006 Accomplishments

I. Food & Color Additives

• Food Contact Notifications (FCN's): All of the notifications reviewed during the fiscal year (103) were completed within the statutory time frame. Received more FCNs during FY 2006 than any previous year (114).
• Food and Color Additive Petitions: Completed the review of all petitions filed in FY 2005 (seven) within 360 days. Published five final rules in the Federal Register in FY 2006, most notably a rule permitting for the first time the addition of bacteriophage to food to reduce the risk of foodborne listeriosis (71 FR 47729; August 18, 2006). Other final rules include: Vitamin D₃ as a nutrient in cheese and cheese products (70 FR 69435; November 16, 2005); synthetic fatty alcohols (70 FR 72906; December 8, 2005); glycerides and polyglycerides (71 FR 12618; March 13, 2006); and mica-based pearlescent pigments as color additives in food (71 FR 31927; June 2, 2006).
• Threshold of Regulation Exemptions: Completed the review of eleven industry submissions for threshold of regulation exemptions and authorized the use of new packaging materials for holding foods during irradiation to increase microbiological safety of food.
• GRAS Notifications: Completed the review of twenty-four GRAS Notifications; more than 70% were responded to within the established time frame.
• Color Additives: Analyzed all batches of color additives and determined certification status (certify or refuse to certify) within an average of 5 working days.
• Confirmation of Effective Date: Listing of Color Additives Exempt from Certification:
  1. Tomato Lycopene Extract and Tomato Lycopene Concentrate, Response to Objections and Removal of Stay, 71 FR 9448; February 24, 2006.
  2. Mica-based Pearlescent Pigments to Color Ingested Drugs, Response to Objections and Removal of Stay, 71 FR 31927; June 2, 2006.
  3. Mica-Based Pearlescent Pigments; Confirmation of Effective Date, 71 FR 54411; September 15, 2006.
• Notices of Filing - Food Additive Petitions:
  1. Danisco USA, Inc., 71 FR 7975; February 15, 2006.
  2. ARCH Chemicals, Inc., 71 FR 7975; February 15, 2006.
  3. Danisco USA, Inc., Amendment, 71 FR 24856; April 27, 2006.
  4. Georgia-Pacific Resins, Inc., 71 FR 34623; June 15, 2006.
• Notices of Filing - Color Additive Petitions:
  1. Food Ingredient Solutions, LLC, 70 FR 73252; December 9, 2005.

II. Reports to Congress

• Report to Congress on antibiotics in shrimp imports and the number of positive tests for chloramphenicol.
• Report to Congress on Nutrition Facts labeling violations.
• Report to Congress on the regulatory status of sausage casings and the small intestines of cattle.
• Report to Congress on the cost to implement a mandatory adverse event reporting system for dietary supplements.
• Report to Congress on the findings of the perchlorate surveys of food and bottled water.
• Report to Congress as directed by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

III. Food Labeling

• Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Claim Lean. Proposed Rule, 70 FR 71041; November 25, 2005.
• Health Claims: Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease; Interim Final Rule, 70 FR 76150; December 23, 2005.
• Health Claims: Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries. Final Rule, 71 FR 15559; March 29, 2006.
• Health Claims: Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease. Final Rule, 71 FR 29248; May 22, 2006.
• Denied petition requesting amendment of chocolate standards of identify to specify limits on lead and cadmium content in chocolate products.
• Denied petition seeking the establishment of mandatory premarket safety testing, premarket environmental review, and labeling for all genetically engineered foods/food additives.
• Reviewed two allergen labeling notifications and issued objection letters.
• Responded to over 150 e-mail inquiries on FALCPA.
• Updated the NLEA compliance Program (CP 7321.005) to include FALCPA and trans fat.
• Reviewed and responded to over 2,300 trans fat labeling extension requests.
• Issued a warning letter to Masterfoods USA regarding false and misleading claims on candy products.

IV. Qualified Health Claims: Letters of Denial

• Calcium and Kidney/Urinary Stones; October 12, 2005.
• Zangold^® Lutein Esters, Lutein, or Zeaxanthin and Reduced Risk of Age-Related Macular Degeneration and Cataract Formation; December 19, 2005.
• Green Tea and Reduced Risk of Cardiovascular Disease; May 9, 2006.
• 100 Percent Partially Hydrolyzed Whey Protein in Infant Formula and Reduced Risk of Food Allergy in Infants; May 11, 2006.

V. Qualified Health Claims: Letters of Enforcement Discretion

• Calcium and colon/rectal cancer and calcium and colon/rectal polyps; October 12, 2005.
• Calcium and hypertension, pregnancy induced hypertension, and preeclampsia; October 12, 2005.
• Tomatoes and prostate, ovarian, gastric and pancreatic cancers; November 8, 2005.
• Tomatoes and prostate cancer; November 8, 2005.

Dietary Supplements

• Nutrition Labeling of Dietary Supplements, Technical Amendment, 71 FR 51726; August 31, 2006.
• Withdrawal of Direct Final Rule: Ingredient Labeling of Dietary Supplements That Contain Botanicals; 70 FR 76684; December 28, 2005.
• Request for Comment: Status of Pyridoxamine, 70 FR 69976; November 18, 2005.
• Responded to 49 out of 53 NDIs within the 75-day statutory time frame.
• Reviewed over 290 adverse event reports associated with use of dietary supplement products.
• Reviewed over 2290 30-day structure function label notifications.
• Issued courtesy compliance letters to 55 companies.
• Issued approximately 3000 Certificates of Free Sale for dietary supplements. None is pending or back logged.
• Identified 59 potentially significant violative Cyber sites. Thirty-eight received compliance letters. Five of the remaining 21 were referred to OC for enforcement action and 16 were deferred for reasons including identification that a previous action had already been taken or initiated, the site had been taken down, or the product was discontinued.
• Developed a field assignment for steroid-containing dietary supplements.

VII. Infant Fornula

• Completed 23 of 28 notifications within the 90-day statutory timeframe.
• Completed 18 out of 20 infant formula before-first-processing submissions as required under section 412(d)(3) of the Federal Food, Drug and Cosmetic Act.
• Completed 9 out of 12 export registrations.

VIII. Other FR Documents

• Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk; 70 FR 60751; October 19, 2006.
• Draft Compliance Policy Guide: Guidance Levels for 3-MCPD (3-Chloro-1,2-Propanediol Protein and Asian-Style Sauces: NOA; 71 FR 29651; May 23, 2006.
• Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comment; 71 FR 37083; June 29, 2006.
• Notice of Temporary Marketing Permit: Iceberg Water Deviating from Identity, Temporary Permit for Market Testing; 70 FR 57607; October 3, 2005.

IX. Training/Outreach

• Developed ALERT cards and accompanying educational material to raise food defense awareness with industry, states and local governments.
• Developed and conducted a train-the-trainer session with the ORA Public Affairs Specialists on food defense awareness and the ALERT Program for information dissemination to both internal and external stakeholders.
• Developed, printed and distributed a new "Food Facts from FDA" on the risks of unpasteurized milk and products made with unpasteurized milk.
• Awarded/funded 25 Public Affairs Staff Food Safety Education Projects.
• Gave presentations on nanotechnology at the Nanotechnology in Food & Agriculture Meeting, Washington, DC; Food Law and Regulation Conference, Chicago, IL; and the Nanotechnology Occupational and Environmental Health & Safety Conference, Cincinnati, OH.
• Issued consumer warning about the potential food safety risks during storm-related power outages and flooding, September 1, 2006.
• Issued letter to manufacturers and suppliers concerning the presence of lead in soft vinyl lunch boxes; July 2006.
• Issued statement on report of bioengineered rice in the food supply; August 2006.
• Issued What Consumers Need to Know About Avian Influenza; October 19, 2006.
• Issued Nationwide E Coli O157:H7 Outbreak Associated with Spinach: Questions & Answers (Updated); September 2006.

X. Guidance

Food Defense

• Revised Compliance Policy Guide: Guidance for FDA and CBP Staff - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; NOA; 70 FR 69160; November 14, 2005.

• Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records (Edition 2). NOA; 70 FR 70488; November 22, 2005.
• Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records (Edition 3). NOA; 71 FR 36986; June 29, 2006.
• Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records (Edition 4). NOA; 71 FR 56005; September 26, 2006.
• Developed and beta tested a user friendly software tool for conducting vulnerability assessments using the CARVER approach.

Food Safety

• Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles . NOA; 70 FR 65905; November 01, 2005.
• Guidance to Industry - LACF Electronic Process Filing System; February 10, 2006.
• Managing Food Safety: A Regulator's Manual for Applying HACCP Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems; April 2006.
• Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments; April 2006.
• Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula; March 1, 2006.

Food and Color Additives and Cosmetics

• Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in Food; June 2006.
• Guidance for Industry: Preparing a Color Additive Petition for Color Additives Used in or on Contact Lenses; May 2006.
• Questions and Answers about the Food and Color Additive Petition Process (2006 Update); April 2006.
• Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions; March 2006.
• Estimating Dietary Intake of Substances in Food; August 2006.
• Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition; NOA; 71 FR 28872; May 18, 2006.
• Updated the Redbook chapter on chronic rodent bioassays for detecting carcinogenicity; February 2006.
• Exporting Cosmetics; 2006 Update.

Food Labeling

• FDA's Implementation of "Qualified Health Claims": Questions and Answers; May 12, 2006.
• Guidance for Industry and FDA: Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006; NOA published December 14, 2005; 70 FR 74020. NOA for an addendum; 71 FR 941; January 6, 2006.

XI. Publications

• Food Safety Magazine: How U.S. FDA's GRAS Notification Program Works. December 2005/January 2006 Issue.
• Food Safety Magazine: CFSAN's Risk Management Framework: Best Practices for Resolving Complex Food Safety Risks. February/March 2006 Issue.
• Food Safety Magazine: The Interagency Risk Assessment Consortium: Improving Coordination Among Federal Agencies. June/July 2006 Issue.
• Food Safety Magazine: Food GMP Modernization. August/September 2006 Issue.

XII. Public Meetings

• 2006 FDA Science Teacher Professional Development Program, July 16 - 22, 2006 in College Park, MD.
• Health Claims Public Meeting; November 17, 2005 in College Park, MD (70 FR 60749).
• Amenability Public Meeting; December 15, 2005 in Rosemont, IL.
• Centennial Futures Symposium: Exploring What Lies Ahead; March 29, 2006 in College Park, MD.
• Nationwide satellite downlink presentation on food defense awareness targeted at state and local regulatory agencies, March 29, 2006.
• Co-sponsored the Second Annual International Symposium on Agroterrorism (ISA) with USDA, DHS, FBI and the Kansas City Police Department, September 25 - 29, 2006 in Kansas City, MO. 
• Co-sponsored 2006 Cardiovascular Biomarkers and Surrogate Endpoints Symposium: "Addressing Cardiovascular Risk and Progression," September 18-20 in Bethesda, MD.
• Attended and participated in the planning of FDA's Public Meeting on Nanotechnology Materials in FDA Regulated Products, October 10, 2006, in Bethesda, MD.

XIII. Research and Related Accomplishments

Food Defense

• The Mod 1 Laboratory FERN Pathatrix Training Team trained Medical Emergency Response Team (MERT) members in BSL-3 lab screening protocols and methods for the detection of Yersinia pestis from foods using the Pathatrix system, June 19-23, 2006. Training for the isolation of Y. pestis from food was provided to laboratory personnel from 21 FERN laboratories in preparation for the validation of the Pathatrix Methods.
• Completed validation of Pathatrix methods for the isolation of Y. pestis from five foods in 21 independent laboratories, August 28, Sept. 11, and Sept. 25, 2006.
• Achieved certification from the Department of Homeland Security in the Protection of Critical Infrastructure Information (PCII) system.  FDA/CFSAN is the first federal agency to achieve this.
• Published Summaries of Competitive Food Defense Research Reports,2005; June 2006.
• Coordinated the development of the protocol for and the performance of an emergency notification test to access the accuracy of the emergency contact information in the BT registration database.
• Completed FERN/LRN Proficiency Testing with a perfect score.

Other Accomplishments

• The Bioresearch Monitoring Program issued six GLP Quality Systems Inspection assignments and one directed GLP assignment to the field. In addition, two carryover Quality Systems Inspections postponed in FY'05 were completed.
• Developed analytical methodology and survey data to rapidly investigate the formation of benzene in products containing benzoate preservative and ascorbic acid.
• Developed validated methodology for furan in snack and other foods and exposure data to enable CFSAN's Cancer Assessment Committee to begin the evaluation of the carcinogenic risks from furan in foods.
• Completed cosmetics research on retinol, retinoic acid, retinyl palmitate; 4-aminobiphenyl; p-phenylenediamine (unapproved for use on the skin) percutaneous absorption of lawsone; and nanoscale quantum dots in tissues. Directed research focusing on two collaborative projects with NTP/NCTR on percutaneous absorption of nanoparticles.
• Participated with the FBI in Scientific Working Group for Microbial Genetics and Forensics to develop guidelines for forensic investigations.
• Served on Microbe Project Interagency Working Group to coordinate government agencies' efforts in genomic analyses of microbes.
• Initiated complete genomic sequencing of 18 Salmonella outbreak strains in collaboration with The Institute for Genomic Research (TIGR), supported by NIAID.
• Completed developmental toxicity studies of mycotoxins in rodents. The studies showed that Aminopentol did not cause birth defects.
• Developed methods for the rapid detection of Staph enterotoxins.
• CFSAN's Office of Applied Research and Safety Assessment received designation by the Department of Homeland Security as a Center of Excellence for enteric pathogens.
• Completed sequencing Enterobacter sakazaki protease gene.
• Conducted microarray analysis of genetic diversity among Listeria strains from multiple sources.

XIV. Other Food and Cosmetic Safety Accomplishments

• Worked with the beverage industry to reformulate products to minimize benzene levels.
• Continued implementation of the Produce Safety Action Plan; reviewed and commented on commodity specific guidance for lettuce and tomatoes issued by respective industries; participated in a joint FDA/JIFSAN international GAPs training in Mexico, El Salvador, and China; reviewed Mexican cantaloupe packages under MOU and spearheaded development of Salinas Valley Leafy Green Safety Initiative.
• Participated in US/Mexico Border Health Commission activities to address lead hazards in Mexican candy, ceramics, and home remedies.
• Updated and posted on the web site an acrylamide data and exposure assessment and a dioxin data and exposure assessment.
• Participated in foreign compliance inspections in New Zealand, El Salvador, Nicaragua, and Honduras.
• Conducted dairy training in Panama - requested by USDA -FAS.
• Issued and completed gourmet raw milk cheese assignment.
• Renewed the InterCenter Agreement (ICA) with the Center for Drug Evaluation and Research concerning products that purport to be cosmetics but that meet the statutory definition of a drug, Drafted and reviewed documents for warning letters issued under the ICA.

XV. International Affairs

• Received 96 delegations bringing a total of 512 visitors from 57 countries to improve international compliance and achieve resolution of technical safety issues, thereby assuring improved safety of foods and cosmetics imported by the United States.
• Participated in the U.S. negotiations on SPS portions related to 17 bilateral and free trade agreements, resulting in completion of the CAFTA (Central America)-Dominican Republic, Australia FTA, Morocco FTA, and Bahrain FTA; conclusion of negotiations with Colombia, Peru and Panama; on-going negotiations with Thailand, Qatar, Yemen, Oman, United Arab Emirates, Korea, and Malaysia; and on-hold negotiations with Ecuador, South African Customs Union (SACU) and the Free Trade Area of the Americas. Successful efforts resolved difficult trade issues and allowed the negotiations to be concluded, enabling free movement of U.S. trade goods into those countries.
• Collaborated with the HHS Office of Global Health Affairs, the FDA's Office of International Programs, and USDA's Foreign Agricultural Service to explain FDA's food safety system to Bahrain (the host country), Saudi Arabia, Oman, Yemen, the United Arab Emirates, Qatar, Jordan, Iraq, Kuwait and Lebanon, so that these countries will eliminate barriers to trade of U.S. goods and put in place more effective systems for assuring the safety of their domestic and exported foods, including control of Avian Influenza.
• Collaborated with USDA-FAS to update data, design, and mount a revolutionary comprehensive food export certificate website on the USDA-FAS internet site to provide U.S. and international food exporters and global import authorities with information essential to certification and the smooth flow of traded foods. See http://www.fas.usda.gov/itp/ofsts/exportcertif/intro.asp
• Through the U.S. Enquiry Points, notified the World Trade Organization on 25 proposed and final CFSAN rules.
• Reviewed 169 foreign World Trade Organization notifications and prepared comments on 32% (60) in development of US positions on impact of food safety and trade-related concerns with foreign proposed rules.