U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 1999

Dear Colleague, FDA Foods Community:

Five months ago, you received a copy of CFSAN’s 1999 Program Priorities document. This document constitutes the Center"s priority workplan for the year. I want to provide you a status report of our progress towards implementing the workplan.

First, I want to give you an update on our program priority accomplishments through July 1. In this regard, we have fully completed 14 of the 70 "A" list items -- i.e., activities that we are committing to complete by the end of 1999. These accomplishments are listed in Enclosure 1, the most recent of which is a proposed rule to enhance the safety of shell eggs. In addition to these fully completed activities, we have made substantial progress towards completion of several other "boulders." An illustrative list of these milestones is found in Enclosure 2. I am pleased with the progress being made, even as we also address unanticipated issues such as recent concerns about potential dioxin-contamination in certain European imports.

Finally, I want to inform you about modifications we have made to our 1999 workplan as a result of new information. As I noted in the cover letter to the program priority document, we committed to review our program priorities every four months to ensure that we are continuing to focus our efforts on the real public health issues. Thus, if new information becomes available throughout the year that necessitates a change in our priorities, the four-month review would provide a conscious opportunity to re-direct our efforts. We recently completed our first four-month review, and as a result, have added five new activities to the "A" list, including participation in the strategic planning process under the President’s Council on Food Safety. Two activities were also added to the "B" list. Enclosure 3 identifies the specific language for these modifications.

In closing, I believe we are making very good progress on our 1999 program priorities, and I will provide you with an additional progress report in the fall. I also want to thank many of you for supporting the management approach we are taking for accomplishing specific public health and program objectives. I welcome any feedback you may have.

Food Safety Initiative

1. Prevention Measures for Eggs: Two accomplishments constitute completion of this activity: (1) A proposed rule on refrigeration of shell eggs at retail and safe handling practices by consumers; and (2) In conjunction with USDA, and in accordance with the Appropriations Conference Report, a status report on actions taken to enhance the safety of shell eggs and egg products was submitted to Congress on March 16, 1999.
2. Food Code: Revisions to the Food Code were completed and a notice of its availability was published in the Federal Register on February 22, 1999 (64 FR 8576). Agencies in 15 States have adopted the Food Code. This exceeds the FY 99 Government Performance and Results Act (GPRA) goal to achieve adoption of the Food Code by 25 percent of States.
3. MOU with FSIS: A Memorandum of Understanding (MOU) with the Food Safety and Inspection Service (FSIS) regarding food establishments under the jurisdiction of both FDA and FSIS was finalized on March 1, 1999.
4. "Fight BAC!": In conjunction with the Public-Private Partnership for Food Safety Education, food safety education efforts targeted to school children and high risk populations -- i.e., the very young, the elderly, and those with impaired immune systems -- have been initiated.

5. Expedited Review: New procedures have been implemented to expedite the review of food additives that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against human pathogens that may be present in food. Guidance on implementation of the expedited review process was published in the Federal Register on January 5, 1999 (64 FR 517). Food additive petitions for four antimicrobial agents and one for the irradiation of fresh shell eggs are the first petitions to meet the criteria for expedited review.
6. Irradiation Labeling: An advanced notice of proposed rulemaking to solicit comments on whether revisions to the current irradiation labeling requirements are needed published in the Federal Register on February 17, 1999 (64 FR 7834).

7. Citizen Petition: As directed in the Appropriations Conference Report, FDA responded to citizen petition 98P-0968 regarding the labeling of Surimi through publication of a proposed rule to amend the ingredient labeling regulations on April 9, 1999 (64 FR 17295).
8. Food Regulatory Report: As directed in the Senate Appropriations Report, a report to Congress regarding the Agency’s performance on various applications, notifications, submissions, petitions, and requests for advisory opinions was submitted to Congress on April 21, 1999.

9. Nutrient Content/Health Claims: A proposed rule on the applicability to dietary supplements of the FDAMA provisions on nutrient content/health claim notifications based on an authoritative statement was published in the Federal Register on January 21, 1999 (64 FR 3250).
10. Citizen Petition: A response to citizen petition 98P-0509 regarding FDA’s jurisdiction over publications associated with dietary supplements was issued on April 9, 1999.

11. Pesticide Monitoring Improvements Act (PMIA): FDA’s pesticide monitoring data and summary information was made available on the internet, as required by PMIA, on March 31, 1999.

12. Voluntary Reporting: The Cosmetic Voluntary Reporting Program was reinstated effective January 1, 1999.

13. Program Restoration: FDA developed and implemented a plan to restore $2.5 million to the cosmetics program, as provided in the FY 99 Appropriations. A public meeting to solicit input from Stakeholders on development of the plan was held on January 22, 1999.

14. Integrated Food Safety System: In collaboration with CDC, USDA, and state and local governments, continued progress was made towards development of a plan for a nationally integrated food safety system. All three 1999 milestones have been completed: Creation of a Coordinating body to focus on a vision and next steps; establishment of work groups to draft proposed plans and projects; and solicitation of input from stakeholders. A public workshop was held in conjunction with a meeting of the Association of Food and Drug Officials on June 6 in San Antonio, Texas. Long-term planning ideas will be integrated into the strategic planning process being conducted by the President’s Council on Food Safety.

1. Imports
   • Developed a plan outlining how FDA will: (1) Investigate and contain foodborne outbreaks associated with imported food; (2) increase surveillance of imported food overseas and at the border; and (3) conduct foreign country assessment and equivalence activities.
   • Initiated 1,000 sample import/produce survey.
2. Seafood HACCP
   • In collaboration with the Seafood HACCP Alliance, developed Encore follow-on training course for seafood processors.
   • Solicited comments on a "transition" policy describing when scientific issues need to be resolved before FDA will take regulatory action against a processor that has deficiencies in their HACCP system (March 26, 1999, 64 FR 14736).
3. Produce Initiative
   • Promoted use of the Good Agricultural Practices guidance document to domestic and foreign agriculture communities through public meetings on April 6 and April 28, respectively, in conjunction with USDA.
   • Received from the National Advisory Committee on Microbiological Criteria for Foods, recommendations on reducing pathogens on raw sprouts.
4. Additional Prevention Efforts
   • Solicited public comments on establishment of a performance standard for Vibriovulnificus (January 21, 1999, 64 FR 3300).
5. Risk Assessment
   • To aid in conducting risk assessments for Listeria monocytogenes in ready-to-eat foods, and Vibrio parahaemolyticus in shellfish, notices were published requesting the submission of scientific data and information (64 FR 28351 and 64 FR 24664, respectively.)
   • In conjunction with the Risk Assessment Working Group of the National Advisory Committee on Microbiological Criteria for Foods, a public meeting was held on May to provide an opportunity for open discussion of the issues related to the two above-mentioned risk assessments.
6. Premarket Review of Food Ingredients
   • Held a public meeting on March 12 to solicit input from stakeholders on implementation of the FDA Modernization Act (FDAMA) provision on the submission of premarket notifications for food contact substances.
7. Nutrition, Health Claims and Labeling
   • Held a public meeting on May 11 to solicit input from stakeholders on implementation of the FDAMA provisions on health claims based on authoritative statements.
8. Dietary Supplements
   • Held a public meeting on June 8 to solicit input from stakeholders on development of an overall strategy for achieving effective regulation of dietary supplements under the Dietary Supplement Health and Education Act. (A repeat of the east-coast meeting is scheduled for July 20 in Oakland, CA.)
   • Convened a meeting of the Food Advisory Committee on June 25 to discuss "significant scientific agreement" for health claims and GMP’s for dietary supplements.
9. Chemical and Other Contaminants
   • To develop a compliance policy guide for patulin, a mycotoxin frequently found in apple juice and products containing apple juice, the Food Advisory Committee met on June 24 to discuss the sufficiency of a 50 part-per-billion action level to protect public health.
10. Science Base
    • In consultation with the Office of Science, conducted an external review of the Center’s research program and its administration. (CFSAN expects to receive a report of this review in August.)

1. Food Safety Initiative
• President’s Council on Food Safety: Participate on the President’s Council on Food Safety to develop a comprehensive Food Safety Strategic Plan.
• Salmonella enteritidis: Develop, in conjunction with USDA, a coordinated farm-to-table strategy to reduce the risk of Salmonella enteritidis in eggs and egg products.
2. Nutrition, Health Claims and Labeling
   • Surimi: Publish final rule responding to citizen petition 98P-0968 regarding the labeling of surimi, in accordance with the Appropriations Conference Report.
3. Dietary Supplements
   • Strategy for Pearson Court Decision: Develop a strategy to respond to the January 1999, court decision concerning clarification of the significant scientific agreement standard and use of qualified health claims on certain dietary supplement products.
4. Chemical and other Contaminants
   • Bottled Water Feasibility Study: Publish a draft feasibility study of various methods of informing consumers about the contents of bottled water.

1. Premarket Market Review of Food Ingredients
   • FSIS/FDA Simultaneous Review of Food Ingredients in Meat and Poultry: Publish a final rule addressing the simultaneous review of food ingredients used in meat and poultry.
2. International
   • Export Certificates: Develop an agency policy and procedural framework pertaining to FDA’s role and responsibilities in U.S. government issuance of export certificates for foods.

FDA Modernization Act

CFSAN’s 1999 Program Priorities