1

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

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

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

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.

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

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.

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

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.

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.

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