U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
July 10, 2001

Dear Colleague, FDA Food Community:

As promised, I am pleased to report to you on the progress we are making towards implementing CFSAN's 2001 Program Priorities document. This document constitutes the Center's priority workplan for this fiscal year, October 1, 2000 – September 30, 2001. 

First, we have fully completed 53 "A" list goals (compared to 23 "A" list items at this time last year, and 14 "A" list items at this time two years ago.)  These accomplishments are listed in Enclosure 1. Most notable among these are:  Final rules on egg safety and juice safety; draft risk assessments on Listeria monocytogenes and Vibrio paraheamolyticus; proposals on biotechnology premarket notification and voluntary labeling; a reorganization of our Office of Premarket Approval into a new Office of Food Additive Safety; and recent activities related to BSE prevention, StarLink corn and food allergens.

Second, I want to inform you about modifications we have made to our 2001 workplan. As a result of new priorities, 17 activities were added to the "A" list. Enclosure 2 identifies these modifications.  You will see that the majority of the new priorities fall within the three areas just mentioned:  BSE prevention, StarLink corn, and food allergens. To make time for these emerging priorities, Enclosure 2 identifies ten goals that have been moved to the B* List, so that final action should not be expected until next year. 

Lastly, I want to ask for your input as we begin to establish program priorities for fiscal year 2002. A Federal Register notice will publish shortly requesting comments on our 2002 workplan. The workplan will set forth the Center's program priorities for October 1, 2001 through September 30, 2002. This priority-setting process will continue to provide predictability, transparency, and accountability to our foods program, as we continue to build a World Class Organization.

In closing, I believe we are making excellent progress on our 2001 program priorities, all for the benefit of American consumers.  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.

Sincerely, Joseph A. Levitt Director Center for Food Safety and Applied Nutrition

Enclosures:

1. Fully Completed "A" List Goals
2. Modifications to 2001 Workplan

Enclosure 1

Imports

1. Published guidance for field personnel to ensure that imported food is held in secure facilities until FDA has reviewed and released the shipments into domestic commerce. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~lrd/tpimport.html.
2. Published a proposed rule on the marking of refused food shipments (66 FR 6502; January 22, 2001).
3. Published guidance for field personnel on the imposition of civil money penalties, under Customs' authority, related to the importation of unsafe food. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~lrd/tpimport.html.
4. Continued to advance international food safety efforts by conducting an outreach training workshop entitled, "Food Safety Initiatives Influencing Public Health and Trade" in Midrand, South Africa, on March 27 – 29, 2001.

Seafood Safety

5. Completed an evaluation of FDA's Seafood HACCP program for calendar years 1998 and 1999. A copy of this evaluation is available on our web site at www.cfsan.fda.gov/~comm/seaeval.html.
6. Issued a "Mid-Course" correction to the Seafood HACCP program to focus on processors whose products present the highest risk to consumers. These include firms that need to control for pathogens; firms that need to control for histamines (these can cause allergic reactions); and firms that do not have HACCP plans. A copy of this document is available on our web site at www.cfsan.fda.gov/~comm/shaccp1.html.
7. Published a draft risk assessment on the relationship between Vibrio parahaemolyticus in raw molluscan shellfish, specifically oysters, and human health (66 FR 5517, January 19, 2001).
8. Issued advice to consumers on methyl mercury in fish, and initiated a public education program. Additional information on this issue is available on our web site at www.cfsan.fda.gov/~lrd/tphgfish.html.

  Fruits and Vegetables

9. Published the final rule on HACCP for fruit and vegetable juices to improve their safety (66 FR 6137; January 19, 2001).
10. Completed an evaluation of information from the sampling assignment to analyze 1000 imported produce samples for the presence of microbial pathogens. A copy of this evaluation is available at www.cfsan.fda.gov/~dms/prodsur6.html.
11. In collaboration with the Joint Institute of Food Safety and Applied Nutrition (JIFSAN), conducted two Regional Good Agriculture Practices Training Programs as "Train-the-Trainer" courses. The training programs were held May 28 through June 2, 2001 in Central America, and June 4 – 8 in Brazil.

Egg Safety

12. Published the final rule on egg labeling and refrigeration (65 FR 76091; December 5, 2000).

Listeria

13. Published, for public comment, a draft risk assessment on Listeria monocytogenes contamination in food (66 FR 5515; January 19, 2001). (Jointly with USDA).
14. Published, for public comment, a draft action plan to reduce Listeria monocytogenes contamination in food (66 FR 5515; January 19, 2001). (Jointly with USDA)
15. On March 19, 2001, convened a public meeting to solicit comments on the draft risk assessment and draft action plan.
16. Established a mechanism to expand efforts to gather exposure assessment data on Listeria. The data will come from the JIFSAN-NFPA Listeria Retail Food Study. The study will be 18 months in duration.

Education

17. Distributed a senior citizen food safety video and 25 publications as a package to 800 offices of the Administration on Aging; 10,000 senior day care centers; FDA field public affairs specialists; and all county and state Extension service offices.
 

Premarket Review of Food and Color Additives and Food Ingredients

18. Approved five 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 at www.cfsan.fda.gov/~dms/opa-expd.html.
19. Completed the reorganization of the Office of Premarket Approval into the new Office of Food Additive Safety. A letter announcing this reorganization is available on our web site at www.cfsan.fda.gov/~dms/opareorg.html.
20. Submitted a report to Congress on use of FY 2000 additional funds earmarked to accelerate the rate of review of direct food and color additive petitions.

Nutrition, Health Claims and Labeling

21. Issued a letter to manufacturers regarding conventional foods that contain novel ingredients, such as botanicals, that often bear claims to provide certain health benefits. A copy of this letter is available on our web site at http://www.cfsan.fda.gov/~dms/ds-ltr15.html.
22. Issued warning letters to define boundaries among product categories and prevent misleading claims and ensure ingredients in products are safe. Warning letters were issued to ten manufacturers of "protein bars" and to four manufacturers of conventional foods that contain botanical ingredients. Copies of these letters are available at www.fda.gov/foi/warning.htm.
23. Submitted a Report to Congress on the status of the proposed regulation on food irradiation labeling.
24. Submitted a Report to Congress on the adoption of a qualified health claim relating consumption of omega-3 fatty acids to reduced risk of coronary artery disease.

Dietary Supplements

25. Issued a final determination on a proposed health claim for vitamin B and reduced risk of vascular disease in dietary supplement labeling. FDA is using its enforcement discretion to allow appropriately qualified claims about B vitamins, serum homocysteine, and a reduced risk of vascular disease. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr12.html.
26. Issued a final determination on a proposed health claim for antioxidant vitamins and reduced risk of certain kinds of cancer in dietary supplement labeling. FDA determined that there is no significant scientific agreement for the relationship between consumption of antioxidant vitamins and reduced risk of certain kinds of cancer, and that the scientific evidence for a relationship is outweighed by the scientific evidence against the relationship. Therefore, FDA determined that such a proposed claim can not be made non-misleading with a disclaimer or other qualifying language. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr23.html.
27. Issued a final determination on a proposed health claim for vitamin E and reduced risk of heart disease in dietary supplement labeling. FDA determined that there is no significant scientific agreement for the relationship between consumption of supplemental vitamin E and reduced risk of heart disease, and that the scientific evidence for a relationship is outweighed by the scientific evidence against the relationship. Therefore, FDA determined that such a proposed claim can not be made non-misleading with a disclaimer or other qualifying language. A copy of this letter is available on our web site at www.cfsan.fda.gov/~dms/ds-ltr16.html.

Chemical Contaminants, Pesticides and Other Hazards

28. Developed a strategy to expand dioxin surveillance and issued a field assignment to collect and analyze 500 food samples for dioxin.  Testing is to be done at ORA's Arkansas Research Laboratory (ARL).
29. Published the final "channels of trade" guidance for industry on foods containing methyl parathion residues (66 FR 1246; January 5, 2001).
30. Published guidance to the industry on testing for Starlink corn (66 FR 6627; January 22, 2001).
31. Collected 236 samples of foods made from corn products or corn meal and tested them for the presence of StarLink corn.  Six products were found to contain StarLink corn. All products remaining on the market with positive findings were recalled.
32. Developed a laboratory method to detect antibodies to the Cry9C protein. This was necessary for subsequent allergen testing as the existing tests could only detect antibodies to Cry9C DNA.
33. Provided information to with CDC on a study to determine if any consumers who reported adverse events following consumption of foods made with corn have mounted an antibody response to the Cry9C protein. The results of this investigation, which showed no immune reactions in the consumers, are contained in a  report titled, "Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn" which is posted at: www.cdc.gov/nceh/ehhe/Cry9cReport/cry9creport.pdf.
34. Conducted an inter-laboratory validation study of an ELISA method for the detection of the Cry9C protein in processed foods, and shared the results with EPA.
35. Published a Direct Final Rule to adopt EPA's regulation for disinfection byproducts in public drinking water as a quality standard (66 FR 16858; March 28, 2001). [Note:  Moved up from the "B" list.]  If no adverse comments are received during the comment period, FDA will issue a notice confirming the January 1, 2002 effective date. [Note:  A notice confirming the effective date was published in the Federal Register on July 5, 2001 (66 FR 35439).]

College Park

36. Completed, in partnership with the NTEU, space assignments and furniture selection for the new building in College Park, MD that will house CFSAN headquarters offices and laboratories. Office and laboratory clean-ups have begun.  CFSAN is still targeted to move in the beginning of fiscal year 2002. A dedication ceremony is being planned for early October.

Science Base

37. Established CFSAN Staff College and initiated key "core training" activities.
38. Following review of the animal care and use program and inspection of animal facilities, the program received "full accreditation" by the Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC).

International

39. In February 2001, participated in WHO's Strategic Planning on Food Safety meeting and presented one of six papers.  In March and May, 2001, CFSAN represented the U.S. at meetings of the G8 countries and a larger group of 22 countries to prepare for the Global Forum for Food Safety Regulators meeting that is scheduled for October 2001. This forum will allow countries around the world to discuss food safety problems and solutions.

Biotechnology

40. Published biotechnology mandatory premarket notification proposal (66 FR 4706; January 18, 2001).
41. Published draft guidance for voluntary labeling of foods that have or have not been developed using biotechnology (66 FR 4839; January 18, 2001).

Food Allergens

42. On April 9, 2001, issued a field allergen inspection guide to assist field investigators in assessing conditions that can cause foods to contact allergens. A copy of this document is available at www.cfsan.fda.gov/~dms/wh-alrgy.html.
43. Published a draft Compliance Policy Guide (CPG) entitled "Statement of Policy for Labeling and Preventing Cross-Contact of Common Food Allergens" (66 FR 22240; May 3, 2001). A copy f the CPG is available at www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-250.htm.
44. Provided training for investigators in three districts on how to address food allergens during inspections. The training was videotaped and will be provided to investigators in other District Offices and state regulatory offices.
45. Issued a field assignment to the three District Offices that received training to conduct 8-10 inspections of food firms that produce foods susceptible to contamination with allergenic ingredients. The inspections are targeted for completion within 60 days.
46. To further increase allergen awareness, the eight most common food allergens are being incorporated into broader food safety programs, including the 2001 Food Code, the draft Juice Hazards and Controls Guide, the Seafood Hazards and Controls Guide (3^rd edition), and the Pasteurized Milk Ordinance.
47. Established a web site for all allergen-related documents. The site address is www.cfsan.fda.gov/~dms/wh-alrgy.html.

Transmissible Spongioform Encephalopathy (TSE)/Bovine Spongioform Encephalopathy (BSE)

48. In collaboration with USDA/APHIS, reinforced the existing import ban, with more specific product information on CFSAN-regulated products, including food products, dietary supplements and cosmetics that contain bovine materials from BSE-identified countries, so that banned products do not enter the United States.

Management Initiatives

49. Implemented a pilot project that co-located Administrative Officers (AO's) from their Division to specific program offices to improve administrative support through easier access to the AO by management and staff they service. As a result of the success of this pilot, the Center has permanently co-located the AO's to provide each organizational unit within CFSAN direct access to skilled and experienced administrative support on a day-to-day basis.
50. Enhanced ability to recruit and hire candidates by finalizing a "Strategic Recruitment Plan."  The Plan sets forth goals, objectives, and procedures for recruiting and retaining qualified scientific and professional personnel. As a result of this Plan, CFSAN implemented a variety of aggressive recruitment initiatives including, through June 1, 2001, attendance at approximately 9 job fairs throughout the country, mailings to approximately 500 Colleges and Universities, and successfully hiring 56 new employees of diverse backgrounds.
51. In support of the "Strategic Recruitment Plan," developed and implemented an automated personnel tracking system that enables CFSAN to promptly respond to and make final selection of applicants.
52. Developed two new courses for integration into the core training for CFSAN staff: (1) The Research/Regulations Roundtables explore the interaction of scientific research and the regulations development processes; and (2) The Successions Series which has as its goal to help maintain institutional memory by bringing back former FDA'ers to lecture, lead discussions, and give workshops.
53. Implemented web-based training for new hires as part of the New Employee Orientation Program.

Enclosure 2

The following 17 items emerged as high priority after publication of the FY 2001 Program Priorities document. These are all targeted for completion in FY 2001. Some are already completed, as noted on the previous list and marked here with a double asterisk (**).

Food Safety

1. Methylmercury: Submit a report to Congress on FDA's updated Consumer Advisory regarding mercury exposure from seafood consumption.

Chemical Contaminants, Pesticides and Other Hazards

StarLink Corn: Provide support to EPA in the regulation of StarLink corn:

2. Actively participate in interagency meetings and meetings with industry representatives to ensure a timely and thorough review of issues resulting from the inadvertent contamination of food products with StarLink corn.
3. ** Publish guidance for the industry on testing finished food products for the presence of StarLink corn.
4. ** Collect samples and conduct analyses of food products with corn ingredients for the presence of StarLink corn.
5. ** Develop a laboratory method to detect antibodies to the Cry9C protein.
6. ** Provide information to CDC on a study to determine if any consumers who reported adverse events following consumption of foods made with corn have mounted an antibody response to the Cry9C protein.

 

7. ** Validate the protein test developed by industry to identify the Cry9C protein in finished food products.

Bottled Water: 

8. ** Publish a direct final rule to adopt EPA's regulation for disinfection byproducts in public drinking water as a quality standard.
9. Following close of the comment period, publish a notice in the Federal Register confirming the effective date of the final rule.

Emerging Areas

Food Allergens: Expanded efforts to combat undeclared allergens in food:

10. ** Work with ORA, as necessary, to provide training for field investigators on issues and factors associated with food allergens and sources of cross-contamination.
11. ** Issue a field assignment for a "pilot" inspection program of food firms that produce foods susceptible to contamination with allergenic ingredients.
12. ** Further increase allergen awareness by integrating the eight most common food allergens into broader food safety programs.
13. ** Establish a web site for all publicly available allergen-related documents.

Note: These four items supplement the Food Allergen section of the original Program Priorities document.

Transmissible Spongioform Encephalopathy (TSE)/Bovine Spongioform Encephalopathy (BSE): Initiate activities, as necessary, to prevent TSE's/BSE's, including chronic wasting disease, from posing a public health threat:

14. ** In collaboration with USDA/APHIS, continue to ensure that CFSAN-regulated products, including food products, dietary supplements and cosmetics, that contain bovine materials from BSE-identified countries are restricted entry to the United States.
15. Review existing regulations to determine if enhancements are needed to protect public health from CFSAN-regulated products, including food products, dietary supplements and cosmetics, that contain materials derived from ruminant animals.
16. Review existing regulations to determine if enhancements are needed to protect the public health from chronic wasting disease in elk and deer.

Regulatory Processes

17. Field Workplan: Provide additional specification to FDA's FY 2002 Field Workplan, with respect to inspections and sampling of food, dietary supplements, and cosmetic products.

Due to the need to add additional work to the "A" List, the following ten goals are moved to the "B*" List for the reminder of FY 2001. This means FDA will continue to work on them as time permits, but final action is not expected until FY 2002.

Food Safety

1. Publish a proposed rule for the use of accredited laboratories for testing imported foods.
2. Solicit comments through a public meeting on egg safety proposal (meeting to be held in FY 2002).
3. Produce a video on Good Agricultural Practices/Good Manufacturing Practices for fresh-cut produce, with help from the California Department of Health Services.

Premarket Review of Food and Color Additives and Food Ingredients

4. Formalize procedures for prefiling consultation for new petitions; begin conducting the consultations according to the new procedures.

Nutrition, Health Claims and Labeling

5. Publish a proposal on the sodium proviso of the implied nutrient content claim 'healthy,' and extend the existing effective date for the "second tier" to allow time for new rulemaking.

Dietary Supplements

6. Establish strategy for dietary supplements that contain ephedrine alkaloids based on March 2000 release of AER's and related material and August 2000 public meeting/public comments.
7. Complete Dietary Supplement Labeling Guide.
8. Complete and disseminate dietary supplement research plan.

Emerging Areas

9. 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.

Focused, Economic-based Regulations

10. Publish a proposed regulation on the standard of identify for crabs/names for crabs.

CFSAN 2001 Program Priorities

Hypertext updated by dav/dms 2001-JUL-13