CFSAN 2004 Program Priorities
Accomplishments through June 2004

• Letter from Center Director
• Summary of 2004 Accomplishments through June 2004
• Enclosure 1: Accomplishments through June 2004
• Enclosure 2: Modifications
• Enclosure 3: "B-list" Modifications

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Dear Colleague, FDA Foods Community:

I am pleased to report to you on the progress we are making towards implementing the Center for Food Safety and Applied Nutrition's 2004 Program Priorities. We have made significant progress toward achieving our goal of completing at least 90% of our "A-list" items by the end of the fiscal year.

First, let me mention a few highlights of our accomplishments. On June 4, 2004, CFSAN published a final rule to implement the Administrative Detention provision of the Bioterrorism Act of 2002. We also are on track to publish a final rule implementing the record keeping provision of the Bioterrorism Act by the end of this fiscal year. Extensive outreach has been conducted through public meetings and participation at trade association and other professional meetings to ensure all of our stakeholders are aware the new requirements related to the food facility registration interim final rule, the prior notice of imported foods interim final rule, as well as the authorities and procedures related to Administrative Detention. We have worked diligently to develop numerous user-friendly guidance documents to ensure the requirements are understood and to answer frequently asked questions from our stakeholders. CFSAN is committed to working with and providing assistance to our stakeholders to ensure compliance with these new requirements.

In August 2003, the Food and Drug Administration (FDA) established the Obesity Working Group to confront the current obesity epidemic in the United States and to develop new and innovative ways to help consumers lead healthier lives through better nutrition. FDA Acting Commissioner, Dr. Lester Crawford and I served as Chair and Vice Chair for this priority initiative. I am pleased to report that the Obesity Working Group has delivered a report; "Calories Count," outlining recommended action items and we are taking active steps to implement these recommendations.

We are committed to protecting consumers from misleading claims and unsafe dietary supplements. On February 11, 2004, we published a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug and Cosmetic Act. This final rule was effective April 12, 2004, and it prohibits the sale of dietary supplements containing ephedrine alkaloids because such supplements present an unreasonable risk of illness or injury. Active steps have been taken through the issuance of warning letters to cease the distribution of products sold as dietary supplements that contain androstenedione. Progress continues to be made on the regulations for industry on dietary supplement good manufacturing practices (GMPs).

We have made significant progress on a broad range of goals under all of our program areas. We have fully completed 71 (44%) of our program priority goals as of June 2004. Enclosure 1 provides a "snap shot" of our accomplishments through June 2004. Our focus remains - "doing the most good for consumers and the overall public health" and our priorities continue to reflect this focus. The Center continues to provide substantial international leadership and we remain a world leader in food safety.

Second, let me mention the changes that have been made to our workplan to accommodate numerous unanticipated issues that emerged. Nine new items have been added to our priorities. Enclosure 2 identifies these additions.

As a result of the "A-list" item additions, it was necessary to move several items to the "B-List." This change allows us to devote the appropriate resources to the unanticipated priority issues. The moving of an item to the "B-List" does not indicate that the item is not a priority. Work will continue on these items, however, with the resource adjustments we are not anticipating the work will be completed this fiscal year. We anticipate that these items will return to the "A-List" priorities in fiscal year 2005. Enclosure 3 identifies these changes.

In closing, I believe we are making excellent progress on our 2004 program priorities. I will provide you with a final "Report Card" on our accomplishments in the fall. I welcome any feedback you may have, and encourage you to provide input into the development of next year's workplan.

I thank all of you for your continued support of FDA's foods program.

Sincerely,

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

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FY 2004 Program Priority Status Report

Through June 2004

Accomplished

1. Reopen the comment period for Facility Registration.
2. FR notice of corrections to the Food Registration IFR.
3. Reopen the comment period for Prior Notice.
4. Extension of comment period for Prior Notice.
5. Final rule for administrative detention requirements.
6. Satellite downlink and outreach for prior notice & facility registration.
7. Joint FDA/CBP Plan for prior notice timeframes.
8. SECG on Food Facility Registration.
9. SECG on Prior Notice.
10. Compliance Policy Guide - Prior Notice of Imported Food.
11. Guidance for Industry: Q&As on the prior notice rule.
12. Issue Compliance Policy Guide - Registration of Food Facilities.
13. Issue Guidance on food safety and security for the retail food sector.
14. Issue security guidance for Cosmetics.
15. Conduct food threat assessment evaluations.
16. Participate in emergency response exercises.
17. Provide Emergency Response Training in critical areas in response to acts of terrorism against the food supply.
18. Provide training on the Bioterrorism Rules.
19. Publish a proposed rule to set standards for the use of private laboratories and for testing imported foods.
20. Develop a revised draft of the consumer advisory on methylmercury.
21. Finalize the 1st edition of the Juice Hazards and Controls Guide.
22. Convene public meetings on food cGMPs.
23. Publish for comment a citizen petition to establish a regulatory limit for Listeria monocytogenes in foods.
24. Issue final (draft) CPG on radionuclides in foods.
25. Issue communication on lead levels in candy.
26. Issue assignment to monitor lead in imported candy.
27. Initiate BSE Risk Assessment.
28. Training to teach food safety to child bearing women.
29. Develop Seafood Safety Education Materials.
30. Radio Unica Health Fair Initiative. Preventative controls for industry to reduce the risk of terrorism using the US food supply.
31. Preventative controls for industry to reduce the risk of terrorism using the US food supply.
32. Conduct FAC on methylmercury advisory and issue a revised consumer advisory.
33. Food Safety and Security Health Professionals Program.
34. Establish Agency-wide Obesity Working Group.
35. Issue report outlining OWG strategies.
36. Issue letter to manufacturers -serving sizes.
37. Publish ANPRM for qualified health claims.
38. Extend comment period: Food Labeling, Health Claims; Dietary Guidance.
39. Reopen comment period in response to citizens' petitions (Docket nos. 4P-0390 and 95P-0241).
40. Promote trans fat education and outreach.
41. Extend the comment period for Trans Fatty Acids in Nutrition Labeling.
42. Publish final rule for ephedrine alkaloids.
43. Identify D.S. products that raise safety problems.
44. Food/Color Additive Petitions - Expedited review.
45. Food/Color Additive Petitions - Non-expedited review.
46. Increase enforcement actions for dietary supplement type ingredients in conventional foods.
47. Continue to interact with stakeholders by encouraging prefiling consultations for new submissions.
48. Make publicly available 5 study review templates on the Internet.
49. Develop electronic tracking and filing system for the Office of Cosmetics and Colors.
50. Develop an analytical method for the determination of phthalates in cosmetic products.
51. Conduct a survey of products to determine the contribution of phthalates to human exposure.
52. Establish leveraging activities with the Department of Homeland Security.
53. Nutrition and Foods for Special Dietary Uses (CCNFSDU).
54. Food Import and Export Inspection and Certification Systems (CCFICS).
55. Food Hygiene (CCFH).
56. Methods of Analysis and Sampling (CCMAS).
57. Fish and Fishery Products (CCFFP).
58. Food Additives and Contaminants (CCFAC).
59. General Principles (19th (Extraordinary) (CCGP)).
60. Food Labeling (CCFL).
61. Milk and Milk Products (CCMMP).
62. General Principles (20th Session)(CCGP).
63. TWG for Food Labeling, Packaging and Standards.
64. Enhance the information provided to the public in FDA's evaluation of foods derived from bioengineered plants.
65. Convene a public meeting of the Food Biotechnology Subcommittee.
66. Identify a partner or data source to obtain exposure and other missing data on OTC drugs, dietary supplements, and devices used at home.
67. Complete CFSAN's Risk Management Framework.
68. Complete the FY 2004 budget review.
69. Realign CFSAN's Office of Management Systems' Organizational structure and functions.
70. Establish service level agreements and new modalities for working with the Office of Shared Services.
71. Continue programs and policies to ensure full security over select agents used within CFSAN.

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FY 2004 Program Priorities
Accomplishments through June 2004

Food Security: Implementing New Legislation

1. On April 14, 2004, published a notice in the Federal Register (69 FR 19766) to reopen for 30 days the comment period on the registration of food facilities interim final rule (IFR) that appeared in the Federal Register of October 10, 2003 (68 FR 58894). The Federal Register notice can be found at: http://www.cfsan.fda.gov/~lrd/fr04414a.html.
2. On May 24, 2004, published in the Federal Register (69 FR 29428) notice providing technical amendments to interim final rule for food facility registration Sec 1.231 and 1.232 (21 CFR 1.231 and 1.232) published in the Federal Register October 10, 2003. The notice containing the corrections can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040524.html.
3. On April 14, 2004, published a notice in the Federal Register (69 FR 19763) to reopen for 30 days the comment period for FDA's prior notice interim final rule (IFR) that published in the Federal Register of October 10, 2003 (68 FR 58974). The Federal Register notice can be found at: http://www.cfsan.fda.gov/~lrd/fr04414b.html.
4. On May 18, 2004, published in the Federal Register (69 FR 28060) notice extending to July 13, 2004, the comment period on the prior notice IFR that appeared in the Federal Register of October 10, 2003 (68 FR 58974). The notice can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040518.html.
5. On June 4, 2004, published in the Federal Register (69 FR 31659) a final regulation entitled: "Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which authorizes the use of administrative detention and requires regulations establishing procedures for instituting on an expedited basis certain enforcement actions against perishable food subject to a detention order. This rule was effective July 6, 2004. The rule can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040604.html.
6. On October 28, 2003, CFSAN/FDA held a public meeting via satellite downlink to discuss final regulations implementing two sections in Title III of the Bioterrorism Act regarding Registration of Food Facilities (Docket No. 2002N-0276) and Prior Notice of Imported Food Shipments (Docket No. 2002N-0278). The purpose for the meeting was to provide information on the rules to the public and to provide a comprehensive picture of the rules and provide the public an opportunity to ask questions of clarification. Videos of the October 28, 2003, broadcast are available in English, Spanish and French on the CFSAN Web site at: http://www.cfsan.fda.gov/~comm/vltbtac3.html.

   On April 1, 2004, CFSAN completed the nine-city domestic outreach meetings for small businesses and other stakeholders on the two interim final rules. From April 21-29, 2004, FDA met with over 1,000 government officials, manufacturers, processors, packers, holders, and transporters of foods in a series of outreach meetings on the Registration and Prior Notice regulations. The FDA team conducted international meetings in Beijing, China; Seoul, Korea; Tokyo, Japan; and Bangkok, Thailand. Press briefings and television interviews were conducted during the international tour. The highly successful tour was organized in coordination with the American Embassy in each of the countries visited and in Bangkok, co-sponsored by the National Food Processors Association (Asia Branch). On May 4, 2004, CFSAN staff provided a brief overview of the Bioterrorism (BT) Regulations to the Republic of Armenia delegation in College Park. The delegation consisted of the Assistant Minister; Chief of Veterinary Department; Industry: Bilyan Co (Meat Industry); Atenk Co. (Meat Industry); International Academy of Ecology & Life Protection Sciences (IAElPS) Head of Testing Laboratory; and Ashtarak Dairy.

7. On April 14, 2004, the FDA and the U.S. Bureau of Customs and Border Protection (CBP) announced in the Federal Register (69 FR 19765) the availability of the plan entitled "Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes." The plan, which includes an assessment schedule, describes the process by which FDA and CBP intend to increase integration and examine whether we could amend the timeframe requirements in FDA's prior notice IFR to have the same advanced notice timeframes for arrivals by land via road or rail, or arrival via air that are currently in CBP's advance electronic information rule. The announcement can be found at: http://www.cfsan.fda.gov/~lrd/fr04414c.html.
8. On December 12, 2003, published in the Federal Register (69 FR 69408) a notice announcing the availability of a small entity compliance guide (SECG) for the IFR on Registration of Food Facilities. This SECG restates, in simplified format and language, FDA's current requirements for registration of food facilities. As guidance, this document is not binding on either FDA or the public. FDA notes, however, that the regulations that serve as the basis for this guidance document establish requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult the regulations at 21 CFR part 1, subparts H and I, in addition to reading this SECG. The notice can be found at: http://www.cfsan.fda.gov/~lrd/fr031212.html.
9. On December 12, 2003, published in the Federal Register (69 FR 69408) a notice announcing the availability of a SECG for the IFR on Prior Notice of Imported Foods. This SECG restates, in simplified format and language, FDA's current requirements for Prior Notice of Imported Foods. As guidance, this document is not binding on either FDA or the public. FDA notes, however, that the regulations that serve as the basis for this guidance document establish requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult the regulations at 21 CFR part 1, subparts H and I, in addition to reading this SECG. The notice can be found at: http://www.cfsan.fda.gov/~lrd/fr031212.html.
10. On December 15, 2003, published in the Federal Register (68 FR 69708) a notice announcing the availability of a Compliance Policy Guide (CPG) Sec 110.310 entitled: "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The CPG provides written guidance to FDA staff and the U.S. CBP staff on enforcement of section 307 of the Bioterrorism Act and the Agency's implementing regulations, which require, beginning on December 12, 2003, prior notice for all food imported or offered for import into the United States. The notice can be found at: http://www.cfsan.fda.gov/~lrd/fr031215.html.
11. On December 16, 2003, announced in the Federal Register (68 FR 69957) a notice of availability of the Guidance for Industry: Questions and Answers on the Interim Final Rule on Prior Notice of Imported Food. FDA is issuing the guidance entitled: "Prior Notice of Imported Food, Questions and Answers" as Level 1 guidance. Consistent with FDA's Good Guidance Practices regulation (21 CFR 10.115), the Agency will accept comment, but it is implementing the guidance document immediately, in accordance with Sec. 10.115(g) (2), because the Agency has determined that prior public participation is not feasible or appropriate. The notice can be found at: http://www.cfsan.fda.gov/~lrd/fr031216.html.
12. On December 19, 2003, published in the Federal Register (68 FR 70817) a notice announcing the availability of a CPG Sec. 110.300 entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002." The CPG provides written guidance to FDA staff on enforcement of section 305 of the Bioterrorism Act and the Agency's implementing regulation, which require, beginning on December 12, 2003, registration with FDA for all domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States. The notice can be found at: http://www.cfsan.fda.gov/~lrd/fr031219.html.
13. On December 17, 2003, published in the Federal Register (68 FR 70278) a notice announcing the availability of a guidance document related to food security entitled "Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance." It identifies the kinds of preventive measures that operators may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. The guidance can be found at: http://www.cfsan.fda.gov/~lrd/fr031217.html.
14. On December 17, 2003, published in the Federal Register (68 FR 70278) a notice announcing the availability of a guidance document related to cosmetics security entitled "Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance." The guidance is designed as an aid to operators of cosmetics establishments (e.g., firms that process, store, repack, relabel, distribute, or transport cosmetics or cosmetics ingredients). It identifies the kinds of preventive measures that operators may take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal, or terrorist actions. The guidance can be found at: http://www.cfsan.fda.gov/~lrd/fr031217.html.
15. FDA continued to reassess and revise our food vulnerability assessments during 2004.
16. Emergency Response Exercises: CFSAN participated in numerous emergency response exercises that included all levels of government:
    • January 2004, CFSAN participated in the TOPOFF 3 Exercise Command Post Exercise Initial Planning Conference.
    • March 2004, CFSAN participated in an FDA-wide radiological emergency functional exercise. The purpose of the exercise was to test FDA's Radiological Emergency Response Plan. CFSAN activated the "CFSAN Situation Room" and responded in accordance with the CFSAN Emergency Response Plan and the FDA Radiological Emergency Response Plan.
    • March 2004, CFSAN attended a Restaurant Association of Maryland Table Top Exercise Steering Advisory Committee Meeting. Representatives from the Department of Homeland Security, the U.S. Department of Agriculture, the University of Maryland and various MD state agencies were also present.
    • May 2004, FDA participated in an FDA Biochem Exercise.
17. Emergency Response Training: The CFSAN Emergency Response Plan (CERP) was revised, posted on CFSAN's intranet and distributed. In cooperation with CFSAN's Staff College, a workshop was conducted to prepare the "CFSAN Situation Room" Staff for a 3-day course at the Emergency Management Institute in Emmitsburg, MD and refresher Emergency Management Training for CFSAN leadership.
18. Training on the Bioterrorism Final Rules: Training on two of the four BT Regulations, Registration and Prior Notice of Imports, has been completed. A worldwide "Satellite downlink" public broadcast on the two final regulations was held on October 28, 2003. On the 3^rd and 7^th of November 2003, FDA held (1) Bioterrorism Legislations' Rules and Procedures - Handling questions (Satellite Downlink); and (2) Implementing the Bioterrorism Legislation's Rules and Procedures.
19. On April 29, 2003, published in the Federal Register (69 FR 23460) a proposed rule on requirements pertaining to sampling services and private laboratories used in connection with imported food. The proposal would require samples to be properly identified, collected, and maintained. Additionally, the proposal would require laboratories to use validated or recognized analytical methods, and to submit analytical results directly to FDA. The proposal is intended to help assure the integrity and scientific validity of data and results submitted to FDA. The proposed rule can be found at: http://www.cfsan.fda.gov/~lrd/fr040429.html.
20. On March 19, 2004, FDA and the Environmental Protection Agency (EPA) announced the joint consumer advisory entitled: "What You Need to Know about Mercury in Fish and Shellfish." The joint advisory made several recommendations for reducing exposure to high levels of mercury in women who may become pregnant, pregnant women, nursing mothers, and young children. This unifies advice from both FDA and EPA and supersedes FDA's and EPA's 2001 advisories. The advisory can be viewed at: http://www.cfsan.fda.gov/~dms/admehg3.html.
21. On March 3, 2004, published in the Federal Register (69 FR 10051) a notice announcing the availability of a guidance document related to the processing of juice entitled: "Guidance for Industry: Juice HACCP Hazards and Controls Guidance, First Edition." The guidance represents FDA's views on potential hazards in juice products and recommends how to control such hazards and it is designed to assist juice processors in the development of their HACCP plans. The guidance can be viewed at: http://www.cfsan.fda.gov/~dms/juicgu10.html.
22. On May 21, 2004, announced in the Federal Register (69 FR 29220) three public meetings intended to obtain comments about FDA's Good Manufacturing Practices (GMPs) in manufacturing, packing, or holding human food regulations (21 CFR part 110). The announcement can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040521.html.
23. On May 24, 2004, issued in the Federal Register (69 FR 29564) a notice announcing that a petition has been filed that requests that the Agency 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. The Agency is requesting comments on the petition. The notice can be viewed at: http://www.cfsan.fda.gov/~lrd/fr04524b.html.
24. On January 14, 2004, published in the Federal Register (69 FR 2146) a notice announcing the availability of a draft CPG entitled: "Guidance Levels for Radionuclides in Domestic and Imported Foods." The draft CPG rescinds and replaces the current CPG Sec. 560.750 Radionuclides in Imported Foods -- Levels of Concern (CPG 7119.14). The draft CPG provides updated guidance levels for radionuclide activity concentration in food offered for import and makes these same guidance levels for radionuclide activity concentration applicable to food in domestic interstate commerce for the first time. The CPG can be found at: http://www.cfsan.fda.gov/~dms/cpgnuc.html.
25. On March 25, 2004, issued letters to manufacturers, importers and distributors of imported candy. The letter is to inform applicable parties of actions the FDA intends to take to reduce further the potential exposure of children to lead from candy products. The letter can be viewed at: http://www.cfsan.fda.gov/~dms/pbltr.html.
26. Reviewed all FDA data on lead in imported candy from FY 2000 through FY 2004 and collaborated with FDA's field offices to prioritize categories of Mexican candy for sampling.
27. Initiated work on a BSE risk assessment. Harvard University is in the process of modifying the BSE risk assessment model to use the available data to accommodate FDA-regulated products.
28. In our effort to train health educators to teach food safety to pregnant women and women who may become pregnant about the risks of methylmercury in seafood and Listeria monocytogenes in refrigerated food, print materials and videos are completed and in distribution to targeted audiences(s) in English only. By September, we will distribute the same information in Spanish.
29. In our effort to develop and distribute seafood safety education materials, methylmercury advisory information and fotonovellas for Vibrio vulnificus in seafood are completed and in distribution to targeted audiences nationwide.
30. In FY 2004 CFSAN exhibited and distributed Spanish and English food safety materials at seven Radio Unica health fairs held in San Francisco, Miami, Houston, Dallas, San Antonio, Phoenix, and McAllen, TX. These followed four Radio Unica health fairs held in FY 2003 in New York, Los Angeles, Chicago, and Fresno. In total, the fairs attracted more than 25,000 people, and the 60-second health messages broadcasted in conjunction with the health fairs reached some 14.1 million Hispanic adults. Univision Network's Radio Division has taken over a number of Radio Unica's programs, including the health fair series, and it plans to begin a new series in August 2004.
31. On May 28, 2004, completed a review of the preventive controls that industry may take to reduce the risk for an intentional act of terrorism or contamination using the US food supply for high risk and medium risk food commodity/agent combinations. Briefing for FDA officials was held on June 17, 2004.
32. On December 10-11, 2003, FDA's Food Advisory Committee (FAC) met to provide a status report and response to the FAC recommendations on methylmercury in fish and shellfish. The transcripts can be viewed at:
    http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4010t1_.htm
    http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4010t2_.htm
33. On April 7, 2004, FDA, in partnership with the U.S. Centers for Disease Control and prevention (CDC), the U.S. Department of Agriculture/Food Safety and Inspection Service (FSIS), the American Medical Association (AMA) and the American Nurses Association (ANA) issued an educational primer entitled: "Diagnosis and Management of Foodborne Illnesses: A Primer for Physicians and Other Health Care Professionals." The new primer will assist physicians and other health care professionals to be aware of what to look for in relation to foodborne disease, whether accidental or deliberate. Health care professionals can request a free copy of the primer by visiting the AMA Web site at: www.ama-assn.org/go/foodborne. Additionally, FDA is assessing venues, techniques, and formats to distribute and communicate to health professionals. This effort is through focus group testing that will be partially completed in September and analysis by the end of 2004.
34. On August 11, 2003, then-Commissioner Mark B. McClellan, M.D., Ph.D., established FDA's Obesity Working Group (OWG). The OWG met eight times; received briefings from invited experts; held one public meeting, one workshop, two roundtable discussions; solicited comments on obesity-related issues for submission to the Docket (Docket No. 2003N-0338); and prepared and delivered a report with recommendations to address the obesity problem from FDA's perspective and authorities.
35. On March 12, 2004, the OWG publicly released its "Calories Count" report. The report contains a series of short and long-term recommendations for dealing with the obesity problem centered on the scientific fact that, at its most basic level, weight control requires caloric balance. The report can be viewed at: http://www.cfsan.fda.gov/~dms/nutrcal.html.
36. As part of FDA's Obesity Initiative, serving size declaration on food products was highlighted as a priority for the agency. CFSAN's Office of Nutritional Products, Labeling and Dietary Supplements issued a "Dear Manufacturer" letter on March 12, 2004, to remind the food industry about the rules for determining appropriate serving size. The "Dear Manufacturer" letter also advised the industry that FDA intends to highlight accurate serving size as an enforcement priority. The letter can be viewed at: http://www.cfsan.fda.gov/~dms/fl-ltr4.html.
37. On November 25, 2003, published in the Federal Register (68 FR 66040) an advance notice of proposed rulemaking (ANPRM) to request comments on alternatives for regulating qualified health claims in the labeling of conventional human foods and dietary supplements. FDA also is soliciting comments on various other issues related to health claims and on the appropriateness and nature of dietary guidance statements on conventional food and dietary supplement labels. The ANPRM can be viewed at: http://www.cfsan.fda.gov/~lrd/fr031125.html.
38. On January 27, 2004, published in the Federal Register (69 FR 3868) an extension of the comment period for the ANPRM entitled: "Food Labeling: Health Claims; Dietary Guidance." FDA extended the comment period for the ANPRM for 30 days, until February 25, 2004. The agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. The notice can be found at: http://www.cfsan.fda.gov/~lrd/fr040127.html.
39. On May 4, 2004, published in the Federal Register (69 FR 24541) a notice reopening for 60 days the comment period for the proposed rule entitled: "Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and other Specific Requirements for Individual Health Claims. In that document, FDA proposed to amend its existing nutrient content claims and health claims regulations to provide additional flexibility in the use of these claims on food products. The notice can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040504.html.
40. FDA Public Affairs Specialists were provided a technical presentation promoting trans fat education and outreach, including a script about the new labeling requirements to facilitate accurate communication to stakeholders. The FDA Consumer featured a cover story about trans fats and all information, including press documents, regulations, Q&A's, and consumer information was posted on the CFSAN Web site. These documents also were sent to CFSAN stakeholders. CFSAN also completed a Web-based interactive article in English and Spanish and a new presentation to accompany the consumer article.The article can be viewed at: http://www.cfsan.fda.gov/~dms/transfat.html.
41. On March 1 and April 19, 2004, published in the Federal Register (69 FR 9559 and 69 FR 20838, respectively) two notices extending the comment period for an ANPRM on Trans Fatty Acids in Nutrition Labeling published in the Federal Register of July 11, 2003 (60 FR 41507). The notices can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040301.html and http://www.cfsan.fda.gov/~lrd/fr040419.html.
42. On February 11, 2004, published in the Federal Register (69 FR 6787) a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act. This rule became effective on April 12, 2004. The rule can be viewed at: http://www.cfsan.fda.gov/~lrd/fr040211.html.
43. Sent warning letters to 23 companies asking them to cease distributing products sold as dietary supplements that contain androstenedione and warning them that they could face enforcement action if they do not take appropriate actions. A Press Release on this is available at: http://www.fda.gov/bbs/topics/news/2004/hhs_031104.html.
44. Food and Color Additive Petitions - Expedited Review: for the petition receipt cohort of FY 2003, met goal to complete within 360 days of filing, the safety evaluation of two of the three food additive petitions that qualify for expedited review. A petition qualifies for expedited review if the food additive is intended to decrease the incidence of foodborne illnesses through its antimicrobial actions against human pathogens that may be present in food.
45. Food and Color Additive Petitions - Non-expedited Review: for the petition receipt cohort of FY 2003, completed within 360 days of filing, the safety evaluation of four (80%) of five food additive petitions that do not qualify for expedited review. This exceeds our goal of completing at least 70% of these petitions within 360 days.
46. In an effort to increase enforcement actions for dietary supplement-type ingredients in conventional foods whose use is neither approved under section 409 nor generally recognized as safe (GRAS), CFSAN sent letters to companies marketing conventional foods containing "kava" and warning letters were sent to companies marketing products containing "stevia."
47. Continued to interact with stakeholders proactively by encouraging prefiling consultations for new industry submissions for food and color additive petition, food contact substance premarket notifications and biotechnology and GRAS consultations. This is evidenced by the successful completion of 64 premarket notification consultations, 12 presubmission meetings with companies submitting food and color additive petitions, 4 presubmission consultation meetings with companies regarding biotechnology products and 10 presubmission consultation meetings with companies regarding GRAS notifications.
48. Issued guidance for industry with five review templates related to the submission of toxicology/safety data submitted in food and color additive petitions and in food contact notifications. The guidance document and review templates is available at http://www.cfsan.fda.gov/~dms/opatoxtm.html.
49. Completed the development of an electronic tracking and filing system to improve workflow, document tracking, and ease sharing of documents and information within the Office of Cosmetics and Colors (OCAC). Historical and new documents are now being entered into the system.
50. Developed an analytical method for the determination of phthalates in cosmetic products. The method determines phthalates in cosmetic products using high performance liquid chromatography (HPLC). A draft manuscript has been prepared for publication of the method, entitled "Analysis of phthalate esters in consumer cosmetic products." The manuscript will be submitted to the Journal of Cosmetic Science.
51. Conducted a survey of products to determine the contribution of phthalates to human exposure. CFSAN's Office of Cosmetics and Colors (OCAC) surveyed 48 cosmetic products and identified 5 phthalate esters in 32 of the products. Phthalate levels ranging from 16 ppm to 59,000 ppm were found; the highest levels found were in nail enamels.
52. Established leveraging activities with the Department of Homeland Security to develop methods for strain attribution of foodborne pathogens; funds have been transferred, deliverables have been identified and a time line for delivery has been developed.
53. Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU): CFSAN provided the U.S. Delegate and Alternate Delegate to CCNFSDU and attended the Committee's 25^th Session of this Codex Committee. CCNFSDU advanced the Codex Proposed Draft Guidelines for Vitamin and Mineral Food Supplements to Step 5 in the 8-Step Codex Step Procedure. Ongoing work of the Committee includes revision to the Codex Standard for Infant Formula, revision of the Codex Standard for Processed Cereal Based Foods for Infants and Young Children, and the development of Recommendations on the Scientific Basis of Health Claims. CFSAN has provided input to the development of these and other documents under development by the Committee.
54. Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS): CFSAN provided the U.S. Delegate to CCFICS and attended the 12^th Session of this Codex Committee. CCFICS completed work on the Codex Guidelines for the Exchange of Information in Food Control Emergency Situations. Work continues on the subject traceability/product tracing for which CFSAN is providing a leadership role. New work is planned on: implementation guidance for equivalence determinations with respect to sanitary measures; risk-based inspection of imported foods; and revision to guidance on certification of foods, including electronic certification. CFSAN is participating in or is leading the work effort in all these new work areas.
55. Codex Committee on Food Hygiene (CCFH): CFSAN provided the U.S. Delegate and Co-Alternate Delegate to CCFH and attended the 32^nd Session of this Codex Committee. The Committee completed work on the Codex Code of Hygienic Practice for Milk and Milk Products, for which the U.S. was the lead drafting country and CFSAN provided the U.S. lead. The Committee also completed work on definitions for food safety objectives, performance objectives and performance criteria, an area which establishes new international concepts for the area of food hygiene and in which CFSAN played a leading role internationally. The Committee has under development a number of important hygiene texts for which CFSAN is providing the Committee lead or leading the U.S. involvement in the Committee's working groups including: Guidelines for Validation of Food Hygiene Control Measures; Principles and Guidelines for Microbiological Risk Management; Guidelines for the Control of Listeria monocytogenes; and the Code of Hygienic Practice for Eggs and Egg Products.
56. Codex Committee on Methods of Analysis and Sampling (CCMAS): CFSAN provided the U.S. Delegate to CCMAS and attended the Committee's 25^th Session. The Committee completed work on Codex General Guidelines for Sampling and Guidelines on Measurement of Uncertainty. The Committee initiated consideration of the handling of methods for the detection of foods derived from modern biotechnology and continued work on other topics including Guidelines for Evaluating Acceptable Methods of Analysis. The Committee also carried out its endorsement of analytical procedures appearing in Codex commodity standards.
57. Codex Committee on Fish and Fishery Products (CCFFP): CFSAN provided the U.S. Delegate to CCFFP and attended the Committee's 26^th Session. The Committee completed work on sections of the Code of Practice for Fish and Fishery Products dealing with Aquaculture and Quick Frozen Coated Products; work continues on other sections of the Code. Work also continues on a model health certificate to accompany export shipments of fish and on various fish standards. U.S, and particularly, CFSAN input has been significant in all of this work.
58. Codex Committee on Food Additives and Contaminants (CCFAC) : CFSAN provided the U.S. Delegate and Alternate delegate to CCFAC and attended the Committee's 36^th Session. The Committee completed work on Risk Analysis Principles for use of the Committee in its work on food additives and contaminants, a document for which the United States was the lead drafter. With respect to food additives, the Committee continued to progress work on the General Standard for Food Additives, endorsed additive provisions in various Codex Commodity standards, and considered how best to handle processing aids. With respect to contaminants, the Committee completed work on: an initial section of the General Standard for Contaminants and Toxins in Foods; a Policy for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups; the Code of Practice for the Prevention and Adulteration and Reduction of Alflatoxin Contamination in Peanuts; and the Code of Practice for the Prevention and Reduction of Lead Contamination in Foods.
59. Codex Committee on General Principles (19^th (Extraordinary) (CCGP)): CFSAN attended the 19^th (Extraordinary) Session of CCGP that dealt with recommendations resulting from the evaluation of Codex by WHO and FAO. Significant recommendations were made relating to improved management of the Codex standards setting process; the governance of Codex, including the structure and function of the Codex Executive Committee and establishing annual sessions of the Codex Alimentarius Commission; and in the operation of Codex Committees and Task Forces.
60. Codex Committee on Food Labeling (CCFL): CFSAN provided the U.S. Delegate to CCFL and attended the 32^nd Session of the Committee. The Committee completed work on the Codex Guidelines for the Use of Nutrition and Health Claims. Discussions continued on approaches to the labeling of foods derived from modern biotechnology, an area in which countries hold significantly different views and in which the CFSAN has provided significant leadership both within the United States and within Codex. The Committee agreed to undertake a discussion on the appropriateness of developing guidance on advertising with the context of Codex.
61. Codex Committee on Milk and Milk Products (CCMMP): CFSAN provided the U.S. Alternate Delegate to CCMMP and attended the 6^th Session of the Committee. The Committee advanced a number of dairy product standards to Step 5 in the 8 Step Codex Step Procedure (including those for cheddar cheese, whey cheeses, and various dairy fat blends) and continued work on several other dairy product standards. The Committee considered the subject of geographic indicators with respect to the development of a standard for parmesan cheese, an issue on which guidance was requested from the Codex Alimentarius Commission.
62. Codex Committee on General Principles (20^th Session)(CCGP): CFSAN provided the U.S. Alternate Delegate to the 20^th Session of CCGP. The Committee completed work on a definition for traceability/product tracing, an area in which CFSAN has provided leadership, both domestically and internationally. The Committee also forwarded definitions of food safety objectives, performance objectives and performance criteria for use with respect to food hygiene to the Commission for adoption on an interim basis. Work progressed on the development of: proposed Working Principles for Risk Analysis for Food Safety; a revision to the Codex Code of Ethics; guidelines on cooperation with international intergovernmental organizations; and principles and policies for the participation of international non-governmental organizations and observers in Codex.
63. Technical Working Group for Food Labeling, Packaging and Standards: The Technical Working Group (TWG) on Food Packaging, Labeling and Standards held its annual meeting in Washington, D.C., on April 13 and 14. The group discussed a number of important issues, such as FDA's Obesity Initiative, nutrition labeling and claims, trans fatty acid labeling, allergen labeling and legislation, food standards, infant formula, and food safety-related labeling statements and claims.  In addition, the meeting participants identified several items for further follow-up as well as areas for potential harmonization.  This TWG meeting also served as a forum for developing and discussing mutual approaches on labeling issues that were put forward at the 32^nd Session of the Codex Committee on Food Labeling, which was held on May 10-14 in Montreal, Canada.  This year's TWG meeting was co-chaired by Mr. Greg Orriss, Director, Canadian Food Inspection Agency, Mr. Giovanni Bravo, Ministry of Economy, Mexico City, Mexico , and Dr. Laura Tarantino, Acting Director, Office of Nutritional Products, Labeling and Dietary Supplements, FDA.
64. As part of the CFSAN's effort to enhance the information provided to the public in FDA's evaluation of foods derived from bioengineered plants, an updated web page was developed which shows the list of biotechnology consultations that CFSAN has completed. The Web page can be viewed at: (http://www.cfsan.fda.gov/~lrd/biocon.html).

    CFSAN's Office of Food Additive Safety has conducted outreach activities to interested stakeholders. This includes individuals and groups from foreign governments, industry groups, consumer interest groups, and academics. In the period from January-May, 2004, CFSAN has held 13 meetings in order to explain to the public FDA‘s policy for evaluation bioengineered crop plants.

65. On September 24th, CFSAN held the second meeting of the Food Biotechnology Subcommittee of the Food Advisory Committee, in Washington, D.C. The subcommittee was chaired by Dr. Frank Busta of the University of Minnesota. The members included academic representatives, a consumer representative, and an industry representative with expertise in food biotechnology and plant breeding. The subcommittee was asked to consider the use of molecular biology data and information for assessing the safety of new bioengineered foods and to provide suggestions to FDA on any new developments that might enhance the agency's evaluation of these foods. The subcommittee generally supported the new Codex guidelines and FDA's current approach that emphasizes ensuring that new substances in food are safe for consumers.
66. Identified three data sources to obtain exposure and other missing data on dietary supplements and other CFSAN-regulated products.  The data sources are: (1) the Slone Survey, (2) the Behavioral Risk Factors Surveillance Study (BRFSS) and (3) the American Association of Poison Control Centers (AAPCC). Data collection from each source is underway.
67. On February 5, 2004, completed CFSAN's Risk Management Framework. Risk management is the process of weighing policy alternatives and implementing appropriate control options, including regulatory measures. CFSAN's risk management framework builds upon this foundation and includes how projects are identified, prioritized, completed and procedures for monitoring and re-evaluating outcomes of the decisions. The seven components of the CFSAN Risk Management Framework are trigger/inputs, prioritization, process, decision, implementation, outcome, and monitor/evaluate/modify. Training on implementation of the Risk Management Framework for CFSAN management and staff is underway.
68. The budget review for FY 2004 is complete and all priority funding needs have been identified. The budget situation will be monitored to ensure all essential items will be funded.
69. CFSAN's Office of Management Systems (OMS) has been realigned to reflect the establishment of FDA's Office of Shared Services. OMS now focuses on delivering efficient and effective services that do not duplicate those offered at the Agency level but rather complement shared services and fully meet the CFSAN user community's needs.
70. With the advent of the Agency's Office of Shared Services, CFSAN has established, within the OMS, a Shared Services Liaison Group. This group is responsible for establishing service level agreements and monitoring services provided by the Agency's Office of Shared Services to ensure that the CFSAN user community is receiving the necessary administrative and information technology services critical to the Center's mission. This liaison group has become the "consumer advocate" for the CFSAN user community.
71. CFSAN has implemented programs and policies to ensure full security over select agents used within CFSAN. All applicable laboratories are electronically secured with limited access and the research facility at Muirkirk road is a fully secure location.

 

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FY 2004 Program Priorities:
"Modifications"
(i.e., "New Priorities")

The following nine new goals emerged as high priority after publication of the FY 2004 Program Priorities Document. These goals (except #7) are all targeted for completion before the end of FY 2004.

Food Security: Emergency Preparedness:

1. Complete the food security section of the FDA Counter Terrorism Research Report to Congress [Public Health Security and Bioterrorism Preparedness and Response Act of 2002] (P.L. 107-188).
2. Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - Reopening of the Comment Period. Published April 14, 2004 (69 FR 19766).
3. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act 2002 - Reopening of the Comment Period. Published April 14, 2004 (69 FR 19765).
4. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - Extension of the Comment Period. Published May 18, 2004 (69 FR 28060).
5. Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Technical Amendment. Published May 24, 2004 (69 FR 29428).

Chemical Contaminants, Pesticides and Other Hazards

6. Issue draft Compliance Policy Guide on radionuclides in foods to update existing levels and to add radionuclides.
7. Issue draft revised guidance on lead levels in candy. (B-list goal)

Transmissible Spongiform Encephalopathies (TSEs)

8. Publish a proposed rule requiring food and cosmetic processors and manufacturers to maintain records demonstrating that no prohibited cattle materials are used.

Nutrition, Health Claims and Labeling

9. Food Labeling; Nutrient Content Claims, General Principles; Health Claims, General Requirements and other Specific Requirements for Individual Health Claims - Reopening of the Comment Period. Published May 4, 2004 (69 FR 24541).

 

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FY 2004 Program Priorities:
"B-list Modifications"
(i.e., "A-list" Goals Moved to the "B-list")

Due to the additional high priority activities that emerged after the publication of the FY 2004 "Priorities Document," we have moved the following goals to the "B-list" for the remainder of FY 2004. These goals remain a priority and FDA will continue to work on these goals, but we do not expect final action this fiscal year. We anticipate that these goals will be re-positioned to the A-list in our FY 2005 Program Priorities Document.

"Moved to B-list"

Cooperative Programs

1. In conjunction with CFSAN's Office of Compliance and FDA/ORA, achieve adoption of the Food Code in 43 states representing 83% of US population.

Food Allergens

2. Complete an Association of Official Analytical Chemist (AOAC) interlab study for immunochemical peanut protein test kits following the AOAC harmonized validation protocol.
3. Issue draft guidance to the field on the use of test kits to detect the presence of peanut protein.
4. Publish a proposed rule to require the declaration of carmine/cochineal extract, a color additive, on the ingredient statement of food, drug, and cosmetic products containing it.

Education

5. Develop training manual for health educators to teach food safety to pregnant women and women who may become pregnant, in particular safe food handling and education about the risks of methylmercury in seafood and Listeria monocytogenes in refrigerated foods.

Nutrition, Health Claims and Labeling

6. Obesity Message: Develop and begin testing consumer messages tied to "calories count" focus.
7. Publish proposed rule to regulate qualified health claims.
8. Develop guidance for industry on submissions of 75-day pre-notifications for new dietary ingredients.

Science Base

9. Enhance CFSAN's science base and interaction with the academic community through "Centers of Excellence" - host a meeting to present research needs and coordinate activities amongst the existing Centers of Excellence (NCFST, JIFSAN, NCNPR) and other academic counterparts and stakeholder groups.

Internal Processes

10. Work planning: Implement CFSAN's risk management framework which includes incorporation of risk based priorities, best practices, and development of a multi-factorial risk model for both domestic and import operations.
11. Inspections: Identify common factors and a system to assist CFSAN in prioritizing and choosing sites/systems for inspection, including the establishment of a process for conducting statistically based audits of areas not identified as high risk as a means to ensure that the Agency is targeting appropriate sites for inspection and compliance/enforcement activities.
12. Compliance/Enforcement: Establish a process by which CFSAN will set compliance priorities by conducting a series of annual assessments that identify the internal and external hazards a regulated firm faces (e.g., those within versus outside of a firm's control); addressing risk estimate and characterization of the hazards); and determining the consequences to the public health as a result of Agency action vs. inaction.
13. Establish policies and procedures that enhance the use of a tiered approach to foreign food inspections based upon risk for foods so that the amount/type of oversight (e.g., full inspections, abbreviated or focused inspections, evaluations of GMP documents, etc.) is proportional to the degree of risk. Process should be designed to promote development and maintenance of a flexible and risk-based stratified list of foreign facilities requiring inspection to maximize efficient use of foreign inspection resources.
14. Begin to modify CFSAN Compliance Programs, EIR format and the IOM so that during domestic inspections inspectors examine, report, and track counterfeit imported products, returns of imported products, rejected imported products, and complaint files concerning imported products.

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CFSAN 2004 Program Priorities