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                              FOOD ADVISORY COMMITTEE AND DIETARY

 

                                    SUPPLEMENTS SUBCOMMITTEE

 

 

 

 

 

 

 

 

 

 

                                         FURAN MEETING

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                     Tuesday, June 8, 2004

 

                                           1:55 p.m.

 

 

 

 

 

 

 

 

                                       Bethesda Marriott

                                         Grand Ballroom

                                      5150 Pooks Hill Road

                                       Bethesda, Maryland


 

 

 

 

 

 

 

 

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                                          PARTICIPANTS

 

                  Food Advisory Committee

 

                  Sanford A. Miller, Ph.D., Chairman

                  Linda Reed, Acting Executive Secretary

 

                  Douglas L. Archer, Ph.D.

                  Patrick S. Callery, Ph.D.

                  Goulda A. Downer, Ph.D.

                  Johanna Dwyer, D.Sc, RD

                  Jean M. Halloran

                  Norman I. Krinsky, Ph.D.

                  Daryl B. Lund, Ph.D.

                  Margaret C. McBride, M.D.

                  Mark F. Nelson, Ph.D.

                  Robert M. Russell, M.D.

                  Carolyn I. Waslien, Ph.D., R.D.

 

                  Contaminants and Natural Toxicants Subcommittee

 

                  Alex D.W. Acholonu, Ph.D.

                  Marion F. Aller, D.V.M., DABT

                  George M. Gray, Ph.D.

                  Ken Lee, Ph.D.

                  Henry B. Chin, Ph.D.

 

                  Temporary Voting Member

 

                  P. Joan Chesney, M.D.

 

                  FDA

 

                  Dr. Henry Kim


 

 

 

 

 

 

 

 

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                                        C O N T E N T S

 

                                                                          PAGE

 

                  Welcome and Introductions

                  Sanford A. Miller, Ph.D., Chair                            4

 

                  Conflict of Interest Statement

                  Linda Reed, Acting Executive Secretary, FAC                6

 

                  Opening Remarks

                  Nega Beru, Ph.D.                                          10

 

                  Scientific Overview of Furan in Foods

 

                    Analytical Methods/Occurrence

                    Dr. Kim Morehouse                                       22

 

                    Exposure

                    Jeremy Mihalov                                          36

 

                    Formation

                    Dr. Don Forsyth                                         49

 

                  Questions of Clarification                                58

 

                  Scientific Overview of Furan in Foods

                  Dr. Glenda Moser                                          69

 

                  Questions of Clarification                                86

 

                  Public Comment                                            98

 

                  Summary and Charge to the Committee

                  Dr. Terry Troxell                                         98

 

                  Questions of Clarification                               105

 

                  Committee Discussion and Recommendations                 115


 

 

 

 

 

 

 

 

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                                     P R O C E E D I N G S

 

                                   Welcome and Introductions

 

                            DR. MILLER:  I think I would like to get

 

                  started to enable us to finish on time and give

 

 

                  people a chance to make their planes, and so on.

 

                            First of all, let me welcome the new

 

                  members of Food Advisory Committee meeting for this

 

                  afternoon's session, which will deal with furans

 

                  and the data necessary in order to estimate the

 

 

                  risk of furans in food.

 

                            For the record, when I call your name, I

 

                  going to introduce the new members of the

 

                  committee.  This meeting is being held in

 

                  conjunction with the Contaminants and Natural

 

 

                  Toxicants Subcommittee of the Food Advisory

 

                  Committee, and there several members of that

 

                  committee that will be sitting with us in our

 

                  deliberations.

 

                            When I call your name, will you please

 

 

                  just repeat your name and the institution with

 

                  which you are associated.

 

                            First, Dr. Acholonu.


 

 

 

 

 

 

 

 

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                            DR. ACHOLONU:  My name is Alex Acholonu,

 

                  Alcorn State University, Mississippi.

 

                            DR. MILLER:  Dr. Aller.

 

                            DR. ALLER:  Marion Aller with the Florida

 

 

                  Department of Agriculture and Consumer Services.

 

                            DR. MILLER:  Dr. Gray.

 

                            DR. GRAY:  George Gray with the Harvard

 

                  School of Public Health.

 

                            DR. MILLER:  Dr. Lee.

 

 

                            DR. LEE:  Ken Lee with Ohio State

 

                  University.

 

                            DR. MILLER:  Dr. Chin.

 

                            DR. CHIN:  Henry Chin with the National

 

                  Food Processors Association.

 

 

                            DR. MILLER:  Dr. Chesney.

 

                            DR. CHESNEY:  I am Joan Chesney.  I am

 

                  Professor of Pediatrics and Infectious Diseases at

 

                  the University of Tennessee and also the title you

 

                  see on the roster at St. Jude.  I am also here

 

 

                  representing the FDA Pediatric Drug Subcommittee.

 

                            DR. MILLER:  Thank you.

 

                            Since we have some new members, we are


 

 

 

 

 

 

 

 

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                  required to repeat the discussion of conflict of

 

                  interest for this particular issue on furans.

 

                            Linda Reed, who is Acting Executive

 

                  Secretary of the Food Advisory Committee, will read

 

 

                  them.

 

                                 Conflict of Interest Statement

 

                            MS. REED:  Good afternoon, everyone.  As

 

                  Chairman Miller indicated, I am Linda Reed, the

 

                  Acting Executive Secretary of the Food Advisory

 

 

                  Committee meeting.  I would like to welcome

 

                  everyone and particularly our member from CDER.

 

                            I need to read the conflict of interest

 

                  statement into the record again.

 

                            The authority to grant permission to

 

 

                  borrow Special Government Employees currently

 

                  serving on an advisory committee in a sister

 

                  center, in this case, the Center for Drug

 

                  Evaluation and Research, is granted to the

 

                  Associate Commissioner for External Relations, Mr.

 

 

                  Peter Pitts.

 

                            Relying on that authority, Mr. Pitts has

 

                  signed a memorandum granting permission for Dr. P.


 

 

 

 

 

 

 

 

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                  Joan Chesney to serve as a temporary voting member

 

                  for this portion of the meeting concerning furan on

 

                  June 8, 2004.  Dr. Chesney will represent, as she

 

                  just indicated, the Pediatrics Advisory

 

 

                  Subcommittee of the Anti-Infective Drugs Advisory

 

                  Committee.

 

                            Because of the breadth of topics to be

 

                  discussed at this meeting, all of the members and

 

                  temporary voting member have been screened for any

 

 

                  and all financial interests associated with

 

                  regulated industry.

 

                            Based on this review, FDA has determined

 

                  in accordance with 18 U.S.C. Section 208(b)(3) to

 

                  grant general matters waivers to Dr. Marion Aller,

 

 

                  Dr. Douglas Archer, Dr. Johanna Dwyer, Dr. George

 

                  Gray, Dr. Norman Krinsky, Dr. Margaret McBride, Dr.

 

                  Sanford Miller, Dr. Robert Russell, and Dr. Carolyn

 

                  Waslien.

 

                            The granting of these waivers permits

 

 

                  these individuals to participate fully in the

 

                  matters before the committee.  Copies of the waiver

 

                  statements may be obtained by submitting a written


 

 

 

 

 

 

 

 

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                  request to the agency's Freedom of Information

 

                  Office, Room 12A-30 of the Parklawn Building.

 

                            In an effort to enhance consistency within

 

                  FDA, the agency has recently adopted a policy

 

 

                  whereby all public commenters will be asked to

 

                  report any personal financial interests that could

 

                  be affected by the committee's deliberations.  A

 

                  copy of the policy was provided to any individual

 

                  who registered to make comments at this meeting.

 

 

                  Additional copies of the policy may be obtained

 

                  from the registration desk.

 

                            Similarly, we have asked all of our guest

 

                  speakers to complete a financial interest and

 

                  professional relationship certification for guests

 

 

                  and guest speakers to identify any potential

 

                  conflicts of interest.

 

                            Dr. Don Forsyth and Dr. Glenda Moser will

 

                  be the guest speakers at this portion of the

 

                  meeting.  Both have indicated they have no

 

 

                  financial interests in the food industry.

 

                            I would like to thank for your attention

 

                  and I will turn the meeting back over to Dr.


 

 

 

 

 

 

 

 

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                  Miller.

 

                            Thank you.

 

                            DR. MILLER:  Thank you, Linda.

 

                            As a matter of procedure, each of the

 

 

                  speakers have been assigned a time for their

 

                  presentation, and in order for us to make certain

 

                  we get through the presentations, and most

 

                  important of all, the discussion, I intend to be as

 

                  ruthless as I can in keeping the time.

 

 

                            We have several limitations on our time.

 

                  For one thing, we have to be out of here by 6

 

                  o'clock at the very latest.  Otherwise, as I

 

                  indicated this morning, we may be involved in

 

                  somebody else's wedding.

 

 

                            Also, there are some of you who have

 

                  planes to catch, and in order for the committee to

 

                  complete its business, which will be explained in

 

                  just a moment, it is important that we stick to the

 

                  time schedule.

 

 

                            The first presenter is Dr. Nega Beru of

 

                  the FDA, who will provide the background and

 

                  discuss the charge to the committee.


 

 

 

 

 

 

 

 

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                                        Opening Remarks

 

                            DR. BERU:  Thank you, Dr. Miller, and good

 

                  afternoon.  My name is Nega Beru.  I am the

 

                  Director of the Division of Plant Product Safety in

 

 

                  CFSAN's Office of Plant and Dairy Foods.

 

                            My purpose here today is to provide you

 

                  with some of the background on furan in foods to

 

                  set the stage for the scientific overviews that

 

                  will follow immediately.

 

 

                            I will also lay out what input we are

 

                  seeking from the committee.

 

                            The structure of furan is depicted on this

 

                  slide.  It is a 5-member O-ring with two double

 

                  bonds.  It goes by a number of names as shown on

 

 

                  this slide also, has a molecular weight of 68, a

 

                  melting point of -85.6 degrees Celsius, and a

 

                  boiling point of 31 degrees Celsius.

 

                            This last property, it is fairly volatile,

 

                  may be important with respect to how much furan

 

 

                  consumers are exposed to in foods as consumed.

 

                            Furan is a colorless liquid that is used

 

                  in some segments of the chemical manufacturing