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

Dear Colleague, FDA Foods Community:

I am writing to invite you to participate in the upcoming stakeholder outreach meeting scheduled on Wednesday, April 28, 1999, by the Food and Drug Administration (FDA).

You may recall that last year, as part of the Center for Food Safety and Applied Nutrition’s outreach to stakeholders, we held a public meeting on June 24-25, 1998, in Washington, D.C. The stakeholder input received at this meeting was instrumental in CFSAN’s development of our "1999 CFSAN Program Priorities," and FDA’s development of a plan for complying with its obligations under section 406(b) of the Food and Drug Administration Modernization Act of 1997.

In an effort to continue the agency’s collaboration with stakeholders from last summer, FDA is announcing a live satellite teleconference and meetings in eight major cities across the country on April 28, 1999. The teleconference will be held from 1:00 p.m. - 3:00 p.m. Eastern Time with Dr. Jane E. Henney, FDA Commissioner, and Dr. Linda A. Suydam, Associate Commissioner for Strategic Management. Drs. Henney and Suydam will answer questions from viewers and listen to suggestions about how FDA can better carry out its mandates. The FDA downlink sites across the country for the teleconference are listed in the enclosed Federal Register notice, and on FDA’s web page at WWW.FDA.GOV/OPACOM/7MODACT.HTML.

I will be hosting one of the eight regional meetings scheduled for April 28, 1999 in Chicago, Illinois, together with Mr. Raymond Mlecko, District Director, Chicago District Office. This meeting will follow the teleconference, and will be conducted from 3:00 p.m.– 4:30 p.m. Central Time, at the Ralph Metcalfe Federal Building, 77 West Jackson Blvd., Morrison Conference Room, Chicago, IL. If you’re interested in presenting during this meeting, please contact Marquita Steadman of my office at (301) 827-6735 (phone), (301) 480-5730 (fax), or e-mail her at msteadma@bangate.fda.gov by April 9, 1999. If you’re interested in attending the meeting, but not presenting, please contact Kimberly Phillips of the Chicago District Office at (312) 353 - 7126 (phone), (312) 886-3280 (fax), or e-mail her at KPhillip@ORA.FDA.GOV by April 14, 1999. Due to seating limitations, we encourage advance registration.

Please find enclosed the "External Stakeholder’s message" for the April 28, 1999, meeting, a one-page flyer, and a Federal Register notice which provides additional information regarding the teleconference and meetings.

I hope you will join us during this important stakeholder event. Please feel free to send a representative from your organization to join us in Chicago.

Enclosures:

• March 22, 1999 Federal Register Notice (PDF)

• Informational Flyer (PDF)

• Message to Stakeholders

This summarizes general issues and concerns raised at the April 28, 1999, stakeholder meeting. It is not intended to be a detailed account of discussions raised during the meeting. However, more detailed information is provided in the transcript of the meeting which is available on FDA's web site at WWW.FDA.GOV/OC/FDAMA/fdamawebcast/transcripts.html.

Mr. Levitt provided an overview of CFSAN's values, accomplishments, priorities, and challenges. A copy of Mr. Levitt's slide presentation is available at the web address provided above.

Mr. Levitt identified the Center for Food Safety and Applied Nutrition (CFSAN) senior management team. He described the management team's varied background and experiences, and shared commitment to work collaboratively with counterparts at other agencies. Mr. Levitt noted that the consumer wants safe food and it's the responsibility of federal and state food-safety officials to look at their missions more broadly to strengthen the connections. Mr. Levitt said that he is starting this type of collaboration internally at FDA.

Mr. Levitt also discussed FDA values. He stated that it is the agency's goal to have a system that has high standards, that is responsive to stakeholder needs and, above all, has a dedication to excellence and to safe food.

Mr. Levitt listed the food safety initiative (FSI) as CFSAN's number one priority. He described the six major building blocks of the initiative: surveillance, research, risk assessment, education, outbreak response, inspection. He noted that the money that Congress provided to the initiative is not designed to be a one-year fix. It is designed to change the landscape and the direction of how FDA is approaching food safety issues. Mr. Levitt described accomplishments and future activities in FSI. He noted that CFSAN issued a progress report of its accomplishments last year, which is available on CFSAN's web site.

Mr. Levitt described the changing demographics and distribution practices for the food supply. He stated that 50 percent of the dollars Americans spend are on food prepared outside the home. He noted that we also have an increasing vulnerable population. The very young, the elderly, the immune-suppressed, and pregnant women, account for almost 25 percent of the U.S. population.

Mr. Levitt discussed the foods program over the last 20 years. In terms of full time employees, he noted that CFSAN is currently 200 people below where it was 20 years ago. He explained that although CFSAN has received targeted increases for some of its programs, i.e., FSI, its other programs ("the base programs") are suffering. CFSAN is unable to hire more employees for its base programs because it must absorb inflationary increases. Mr. Levitt described how the money allocated to FDA in Fiscal Year 1999 was distributed. In addition, he discussed FDA's FY 2000 budget request.

Given CFSAN's budget reality, Mr. Levitt said the Center must set clear priorities. He noted that this priority-setting effort culminated into the CFSAN priorities document that was issued in January. He explained that the priorities document is not just the Center's workplan, but includes tasks the Center is committed to finishing this year.

In closing, Mr. Levitt said we have to seek ways to enhance a two-way communication with stakeholders. In that regard, Mr. Levitt noted that CFSAN has an established website, conducts ongoing stakeholder meetings, disseminates special mailings, and is establishing a new information and outreach center.

Dr. Armstrong described the National Center for Food Safety and Technology ("National Center", also known as the Moffett Center) in Chicago, Illinois, of which FDA (CFSAN) is a part. He explained that it was initiated to enhance FDA's food science base expertise, expand the FDA's food science research program, cope with emerging food production, processing and packaging technology, and enhance FDA's scientific communication with industry. Dr. Armstrong explained that within the National Center is the Prevention and Intervention Program research program for FDA. Dr. Armstrong noted that this program has a long history of responding to acknowledged food safety issues and engaging stakeholders to address these issues. Dr. Armstrong described some examples of the research that is being conducted at the National Center, including research to enhance the safety of sprouts. He emphasized that the key to the success of this research is technology transfer.

The stakeholders raised the following general issues or themes during the presentations:

Mr. Joseph Doss of Consumer Health Care Products Association (CHCPA) noted CHCPA's support of CFSAN's development of an overall strategy for dietary supplements. He offered a few suggestions on how the agency might go about developing this overall strategy.

Ms. Karen Truskowski of a Multiple Chemical Sensitivity organization raised concerns about fragrances. She stated that the measures in place by the fragrance industry to establish the safety of fragrance materials are inadequate, and provided examples of the problems. Ms. Truskowski stated a need for FDA's intervention to address public health issues associated with fragrance products. Ms. Truskowski provided recommendations for such intervention.

Stakeholders raised the following general issues or themes during the open floor discussion:

Nancy Donnelly of Safe Tables Our Priority (S.T.O.P.), stressed the importance of being truthful in disclosing all of the facts available to the consumer. She commented that the consumer is receiving conflicting messages about the safety of the food supply. Ms. Donnelly offered S.T.O.P's assistance in producing consumer information. She emphasized that the focus of the food safety initiative should not be the safety of the food, but modifying the behavior of the people who handle the food.

Food Code

Ms. Donnelly expressed concern about the possibility of inconsistent adoption of the Food Code among municipalities. She noted that this could lead to a patchwork safety system for food throughout the United States. Consequently, she said there needs to be strong federal regulations throughout the food industry so that there is a level playing field. Ms. Shirley Bohm from the Illinois Department of Public Health noted that her organization is a very strong proponent of the Food Code. She mentioned that due to the size of the document, the state's first step was to incorporate critical sections of the Code. Ms. Bohm noted that the current two-year cycle for issuance of a new Food Code makes it very difficult for the recipients to keep up. Ms. Bohm stated that under the present system, where the Food Code is a recommended document, she expects that there will be some local differences in its adoption.

In response to a question posed by Mr. Levitt, Ms. Bohm noted that if the Food Code were made mandatory, municipalities would need some type of federal funding tied to that adoption. Mr. Ken Moore from the Interstate Shellfish Sanitation Conference commented that the agency will have a unique challenge if it required every state to adopt the Food Code in its entirety. Mr. Moore noted that one of the reasons FDA was able to reach consensus on the Food Code is that states recognize the fact that they would have options when they returned home. Even under a mandatory adoption system, Mr. Moore noted that for intrastate shipments of food, states will continue to have the choice as to how they plan to regulate.

Ms. Meryl Sosa of the Food Animal Concerns Trust ("FACT") noted that their organization advocates animal husbandry systems to improve the safety of milk, meat, and eggs. She expressed concern that there doesn't appear to be any upcoming regulations that would relate to systems on the farm.

Ms. Meryl Sosa questioned whether there was going to be some work within the FDA to try and make FDA personnel more accessible and responsible for responding back to the outside either by e-mail or some other communication. She stated that at a minimum, when comments have been filed in a rulemaking proceeding, the agency should provide some type of status report on the web. Mr. Doss mentioned that the agency should consider having a manual of policies and procedures for meetings. This manual would set forth procedures for scheduling and conducting meetings with outside groups.

The meeting adjourned after Mr. Levitt thanked the attendees, the presenters, and the staff both in Chicago and from Washington.

FDA Modernization Act