U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 2000

Dear Colleague, FDA Foods Community:

As promised, I am pleased to report to you on the progress we are making towards implementing CFSAN’s 2000 Program Priorities document. This document constitutes the Center’s priority workplan for a nine-month period, January 1, 2000 through September 30, 2000. Our highest priorities for the year cover: Food safety, food additives, dietary supplements, and food biotechnology. We are making significant progress in all areas.

First, we have fully completed 23 of the 110 "A" list items (compared to 14 of 83 "A" list items at this time last year). These accomplishments are listed in Enclosure 1. Most notably among these are: (a) Food Safety: Adoption of the Food Code by 20 states (exceeding our 35% goal); (b) Food Additives: Successful launching of the food contact substance notification program; (c) Dietary Supplements: Issuing an import alert on dietary supplements containing aristolochic acid; and (d) Food Biotechnology: Announcing a comprehensive strategy. We also published a series of documents addressing the safety of foods containing chemicals and other contaminants.

In addition to these fully completed activities, we have made substantial progress towards the completion of several other "A" list activities. An illustrative list of these milestones is found in Enclosure 2. I am pleased with the progress being made, even as we also tackle our many important ongoing program areas such as data collection, monitoring, research, and enforcement, as well as responding to unplanned events such as outbreaks of foodborne illness.

Second, I want to inform you about modifications we have made to our 2000 workplan. As a result of new priorities, 11 new activities were added to the "A" list, including a directive from the President to develop an action plan identifying steps necessary to reduce Listeria monocytogenes contamination. These additions caused several activities to be moved to the "B" list. Enclosure 3 identifies these modifications.

Lastly, I want to ask for your input as we begin to establish program priorities for fiscal year 2001. In the Federal Register of June 26, 2000 (65 FR 39415), we published a notice requesting comments on our 2001 workplan. The workplan will set forth the Center’s program priorities for October 1, 2000 through September 30, 2001. This process will continue to provide predictability, transparency, and accountability to our foods program.

In closing, I believe we are making very good progress on our 2000 program priorities. I will provide you with a final "Report Card" on our accomplishments in the fall. Because we condensed implementation of this year’s plan to three-fourths of the year (nine months), our goal is to fully complete at least three-quarters of the "A" list activities. I welcome any feedback you may have, and encourage you to provide input into the development of next year’s workplan.

1. Food Recall Report: In accordance with Senate Report 106-78, submitted a report to Congress regarding recall activities related to foods.

2. Dairy HACCP: In collaboration with the National Conference of Interstate Milk Shippers, initiated a Dairy Grade A HACCP Pilot Program in six dairy processing plants.
3. Produce Sampling Assignment: On May 10, 2000, issued the Domestic Produce Sampling Assignment. The assignment requests collection of 1,000 samples of eight domestically produced fresh fruits and vegetables to determine the incidence of microbial contamination. A copy of the assignment is available on CFSAN’s home page (www.cfsan.fda.gov).
4. Food Code: Agencies in 20 states have adopted the Food Code. This exceeds our goal to achieve adoption of the Code by 35 percent of states.

5. Sprout Video: In collaboration with the California Department of Health Services, the Sprout industry and ORA, developed a video to assist the industry in producing safer sprouts.

6. Expedited Review:Approved three food additive petitions subject to expedited review that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against human pathogens that may be present in food. A list of pending and completed petitions eligible for expedited review is available on our web site at the subheading, "Technical Documents for Industry," under the Food Additives and Premarket Approval program heading.

7. Food Contact Substances: Implemented the food contact substance notification system. Guidance for the industry on preparation of premarket notifications for food contact substances published in the Federal Register on July 13, 2000 (65 FR 43377).
8. Food Contact Substances: A proposed rule to implement the premarket notification process for food contact substances published in the Federal Register on July 13, 2000 (65 FR 43269).
9. Food Contact Substances: The direct final rule and companion proposed rule covering treatment of these notifications under the National Environmental Policy Act published in the Federal Register on May 11, 2000 (65 FR 30352 and 30366, respectively.)

Dietary Supplements

10. Safety Issues: Issued a letter to industry on May 16, 2000, and a separate letter to health care professionals on May 31, 2000, to communicate our concern about the use and marketing of dietary supplements or other botanical-containing products that may contain aristolochic acid. FDA issued an Import Alert on these products on July 6, 2000. Copies of all three documents are available on CFSAN’s home page (www.cfsan.fda.gov).

11. Structure/Function Claims: Published a final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body (65 FR 9999; January 6, 2000).

12. Claims: Following a public meeting, on May 26, 2000 FDA denied a petition requesting authorization of a health claim concerning the relationship between dietary supplements containing saw palmetto and benign prostatic hyperplasia (BPH). FDA’s response noted that claims about effects on existing diseases do not fall within the scope of the health claim provisions of the Act and therefore may not be the subject of an authorized health claim.
13. Dietary Supplement Strategic Plan: On January 3, 2000, the Dietary Supplement Strategic Plan was distributed to stakeholders and posted on CFSAN’s web page (www.cfsan.fda.gov).

14. Implementation of Food Quality Protection Act (FQPA): Published draft guidance entitled, "Guidance for Industry – Channels of Trade Policy for Commodities with Methyl Parathion Residues," in the Federal Register on June 2, 2000 (65 FR 35376). The guidance presents FDA’s policy for foods containing methyl parathion residues in accordance with the "channels of trade" provision of FQPA. [NOTE: Based on EPA’s action on azinphos methyl, a "channels of trade" policy for commodities with azinphos methyl residues is not required.]
15. Patulin: Published a draft compliance policy guide (CPG) entitled, "Apple Juice, Apple Juice Concentrates, and Apple Juice Products – Adulteration with Patulin," in the Federal Register on June 6, 2000 (65 FR 37791). The purpose of the CPG is to advise FDA’s field offices and the industry concerning enforcement actions that may be taken against apple juice products that contain patulin.
16. Pesticide Monitoring Improvements Act (PMIA): FDA’s pesticide monitoring data and summary information was made available on the internet, as required by PMIA, on May 18, 2000.
17. Fumonisin: (1) On January 12, 2000, in collaboration with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the World Health Organization, convened an international workshop to consider all available risk assessment data on fumonisin. (2) Published draft guidance entitled, "Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds," in the Federal Register on June 16, 2000 (65 FR 35945).
18. Bottled Water Feasibility Study: Solicited comments on the draft feasibility study in the Federal Register of February 22, 2000 (65 FR 8718).

19. Streamline Cosmetics Voluntary Registration Program (CVRP): On June 6, 2000, an interactive registration system for streamlining the CVRP was added to CFSAN’s home page. See, "Cosmetic Information for Industry," under the Cosmetics Program Area heading.

20. External Peer Review: On April 21, 2000, presented the External Peer Review Report to the FDA Science Board. The Science Board voted to accept the report. The report’s recommendations are being implemented as outlined at that meeting.

21. World Health Organization (WHO) – Cooperation on Food Safety: The World Health Assembly, under the auspices of the WHO, adopted a resolution on food safety by consensus of all countries. The resolution calls upon WHO to significantly strengthen its leadership role in food safety, particularly with regard to controlling foodborne diseases associated with microbial pathogens.

22. Biotechnology: On May 3, 2000, made a public announcement on plans to strengthen the regulatory approach for bioengineered foods. Three initiatives were announced: (1) Development of a proposed rule requiring that developers of bioengineered foods notify the agency before they market such products; (2) the addition of scientists to the Food Advisory Committee that have expertise in biotechnology; and (3) the development of labeling guidance to assist manufacturers who wish to voluntarily label their foods being made with or without the use of bioengineered ingredients.

23. "New Day": Conducted mandatory conduct and performance training for all employees and mandatory performance management training for all supervisors as a first step towards implementation of the "New Day" in CFSAN.

1. Food Safety Strategic Plan: Working with the President’s Council on Food Safety, developed and solicited public comment on a draft Comprehensive Food Safety Strategic Plan at a public meeting on January 19, 2000.
2. Egg Safety:

• In collaboration with the Food Safety Inspection Service, held two public meetings to solicit and discuss information for reducing or eliminating the risk of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. The Egg Safety National Standards Work Group (composed of representatives from FDA, USDA, and several States) will use the information from the public meeting and written comments to draft proposed national standards for the producer, shell egg packers and egg products processors.

• In conjunction with USDA, published a notice of availability of the agencies’ current thinking papers on national standards for egg safety, and an announcement of a joint public meeting to be held on July 31 to discuss the current thinking papers (65 FR 42707; July 11, 2000).

3. Imports: In collaboration with the U.S. Customs Service, hosted two public meetings to discuss the specific objectives in the President's directive to prevent the importation of unsafe food.
4. Fresh: Announced a public meeting to discuss the use of the term "fresh" in the labeling of foods processed with alternative nonthermal technologies. The purpose of the meeting is to determine whether the use of the term "fresh" is truthful and not misleading on foods processed with these alternative technologies and to determine what type of criteria FDA should use when considering the use of the term with future technologies. The meeting will be July 21, 2000 in Chicago, IL.

• Food and Color Additives: Solicited public comments on ways to improve the process of premarket review and approval of food and color additive petitions in the Federal Register of May 5, 2000 (65 FR 26215).

• Simultaneous Review of Food Ingredients in Meat and Poultry: Published a memorandum of understanding to establish the working relationship to be followed by FDA and USDA/FSIS in responding to requests for the sanctioning of the use of food ingredients and sources of radiation subject to regulation by FDA and intended for use in the production of meat and meat food products (65 FR 33330, May 23, 2000).

• Trans Fatty Acids: Reopened for 60 days the comment period for the submission of comments and other related information regarding the proposed rule on trans fatty acids in nutrition labeling, nutrient content claims, and health claims (65 FR 7806).

• Ephedra:

  1. Published three Federal Register notices announcing the availability of new adverse event reports and related information on dietary supplements containing ephedrine alkaloids, and announcing withdrawal of the provisions of the ephedrine alkaloids proposed rule relating to the dietary ingredient level and duration of use limit for these products (65 FR 17474 - 17510; April 3, 2000).

  2. Published a Federal Register notice (65 FR 32113, May 22, 2000) extending the comment period until July 3, 2000 for the April 3, 2000 Federal Register documents noted above.
  3. On May 23, 2000, informed Congress that the report requested on the Agency’s methodology to be used in Ephedra rulemaking was no longer necessary as certain portions of the proposed rule had been withdrawn by FDA on April 3, 2000.

  4. On June 8, 2000, issued a letter to the Dietary Supplement Community about a public meeting on August 8 – 9, 2000 to discuss the available information about the safety of dietary supplements containing ephedrine alkaloids. The meeting will be convened by the United States Public Health Service. Additional information about the meeting is available at the following internet site: www.4women.gov.

• Pearson v. Shalala: Held a public meeting on April 4, 2000 to solicit comments on implementation of the Court of Appeals decision in Pearson v. Shalala.

• Codex: Participated in 14 Codex committee and related meetings to promote development of harmonized food safety and labeling standards.

Listeria Monocytogenes: In response to the President's May 5 directive, develop an action plan identifying steps necessary to reduce Listeria monocytogenes contamination. The plan should include consideration of control measure for at-risk foods and the publication of guidance for processors, retailers, and food service facilities.

Food and Color Additives: Apply new resources made available in FY-2000 congressional appropriations to make enhancements in the direct food and color additive review program. Issue a letter announcing specific steps being taken, including the preparedness to grant a timely conference with petitioners to provide feedback on petition review progress after filing.

Pearson v. Shalala: By October 10, 2000, make a final determination on the four health claims that were challenged in Pearson v. Shalala (a – d, below) and by November 24, 2000, make a final determination on the plaintiff’s health claim petitions for vitamins B and E (noted below in e and f).

1. Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.
2. Consumption of fiber may reduce the risk of colorectal cancer.
3. Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.
4. 0.8 mg of folic acid in a dietary supplement is more effective in reducing risk of neural tube defects than a lower amount in foods in common form.
5. Three specific claims on the relationship between consumption of Vitamin E and a reduction in the risk of heart disease.
6. As part of a well-balanced diet, rich in fresh whole fruits and vegetables, daily intake of at least 400 micrograms of folic acid, 3 milligrams of vitamin B6, and 5 micrograms vitamin B12 may reduce the risk of vascular disease.

Biotechnology: In accordance with May 3 public announcement:

1. Develop a proposed rule requiring premarket notification of bioengineered foods.
2. Add scientists to the Food Advisory Committee that have expertise in biotechnology.
3. Develop labeling guidance to assist manufacturers who wish to voluntarily label their foods being made with or without the use of bioengineered ingredients.

Food Safety Initiative

1. Methylmercury: Finalize risk assessment of methylmercury based on a subset of data from two key studies.
2. Identification of New Assessment Needs: Establish a process for the selection of pathogens/contaminants and/or commodities for conducting risk assessments.
3. Risk Assessment Education: Develop education and outreach campaigns to communicate the appropriate information learned through risk assessments.

4. GRAS: Develop a final rule codifying the GRAS Notification Program.
5. Pre-filing Guidance: Develop and publish guidance to optimize prefiling interactions between the agency and potential applicants of new direct additives and other food ingredients.

6. Infant Formula Quality Factors: Develop final rule on infant formula quality factors.

7. Infant Formula GMP's: Develop final rule on infant formula Good Manufacturing Practices.

8. Citizen Petition: In response to citizen petitions 94P-0390 and 95P-0241, develop a final rule amending the regulations on nutrient content claims and health claims to provide additional flexibility in the use of these claims on food products.

9. Professional Development: Review current Peer Review Process for research and regulatory scientists.

FDA Modernization Act

CFSAN’s 2000 Program Priorities