34112 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

VI. Analysis of Economic Impacts

A. Benefit–Cost Analysis

FDA has examined the impacts of this

interim final rule under Executive Order

12866. Executive Order 12866 directs

Federal agencies to assess the costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). According to

Executive Order 12866, a regulatory

action is ‘‘significant’’ if it meets any

one of a number of specified conditions,

including having an annual effect on the

economy of $100 million; adversely

affecting in a material way a sector of

the economy, competition, or jobs; or if

it raises novel legal or policy issues.

FDA finds that this interim final rule is

not a significant regulatory action as

defined by Executive Order 12866. In

addition, it has been determined that

this interim final rule is not a major rule

for the purpose of congressional review.

If in the future FDA authorizes health

claims relating to the relationship

between garlic, decreased serum

cholesterol, and the risk in adults of

cardiovascular disease after finding that

there is significant scientific agreement

about these relationships, the cost to

consumers of prohibiting this claim at

this time would be the cost of having

kept, in the interim, information from

appearing in food labeling that would

ultimately be shown to be scientifically

valid, truthful, and not misleading. At

this time, the benefit to consumers of

prohibiting this claim is that a claim

that has not been shown to be

scientifically valid will not appear in

food labeling. Accordingly, consumers

will be able generally to have

confidence when they read food

labeling that any diet/disease

relationship information in that labeling

has been shown to be scientifically

valid.

A health claim relating to the

relationship between garlic, decreased

serum cholesterol, and the risk in adults

of cardiovascular disease has not been

authorized under existing regulations.

The prohibition of this claim in this

interim final rule results in no

regulatory changes for firms, and

therefore no costs to firms are

attributable to this interim final rule.

B. Small Entity Analysis

FDA has examined the impacts of this

interim final rule under the Regulatory

Flexibility Act. The Regulatory

Flexibility Act (5 U.S.C. 601–612)

requires Federal agencies to consider

alternatives that would minimize the

economic impact of their regulations on

small businesses and other small

entities. In compliance with the

Regulatory Flexibility Act, FDA finds

that this interim final rule will not have

a significant impact on a substantial

number of small entities.

A health claim relating to the

relationship between garlic, decreased

serum cholesterol, and the risk in adults

of cardiovascular disease has not been

authorized under existing regulations.

The prohibition of this claim in this

interim final rule results in no

regulatory changes for firms, and

therefore this rule will not result in a

significant increase in costs to any small

entity. Therefore, this rule will not have

a significant economic impact on a

substantial number of small entities.

Accordingly, under the Regulatory

Flexibility Act (5 U.S.C. 601–612), the

agency certifies that this interim final

rule will not have a significant

economic impact on a substantial

number of small entities.

C. Unfunded Mandates Reform Act of

1995

FDA has examined the impacts of this

interim final rule under the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). This interim final rule

does not trigger the requirement for a

written statement under section 202(a)

of UMRA because it does not impose a

mandate that results in an expenditure

of $100 million or more by State, local,

and tribal governments in the aggregate,

or by the private sector, in any 1 year.

VII. The Paperwork Reduction Act of

1995

This interim final rule contains no

collections of information. Therefore,

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520) is not required.

VIII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Notification to Donna E. Shalala, DHHS,

from Jonathan W. Emord et al., Emord &

Associates, P.C., Counsel for Weider

Nutrition International, Inc., February 23,

1998.

2. Letter to Christine Lewis, CFSAN, FDA,

from Eileen Kennedy, USDA, May 7, 1998.

Dated: June 16, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–16460 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0421]

Food Labeling: Health Claims; Zinc

and the Body’s Ability to Fight

Infection and Heal Wounds in Adults

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

interim final rule to prohibit the use on

foods of a claim relating to the

relationship between zinc and the

body’s ability to fight infection and heal

wounds in adults. This rule is in

response to a notification of a health

claim submitted under section 303 of

the FDA Modernization Act of 1997

(FDAMA). FDA has reviewed statements

that the petitioner submitted in that

notification, and, in conformity with the

requirements of FDAMA, the agency is

prohibiting the claim because the

statements submitted as the basis of the

claim are not ‘‘authoritative statements’’

of a scientific body, as required by

FDAMA; therefore, section 303 of

FDAMA does not authorize use of this

claim. As provided for in section 301 of

FDAMA, this rule is effective

immediately upon publication.

DATES: The interim final rule is effective

June 22, 1998; comments by September

8, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Christine J. Lewis, Center for Food

Safety and Applied Nutrition (HFS–

451), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4168.

SUPPLEMENTARY INFORMATION:

I. The FDA Modernization Act of 1997

On November 21, 1997, the President

signed FDAMA into law (Pub. L. 105–

115), which amended the Federal Food,

Drug, and Cosmetic Act (the act).

Sections 303 and 304 of FDAMA
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34113

amended section 403(r)(2) and (r)(3) of

the act by adding new paragraphs

(r)(2)(G), (r)(2)(H), (r)(3)(C), and (r)(3)(D)

to section 403 of the act (21 U.S.C.

343(r)(2)(G), (r)(2)(H), (r)(3)(C), and

(r)(3)(D), respectively), which provide

for the use in food labeling of nutrient

content claims and health claims,

respectively, based on authoritative

statements. FDAMA requires that a

notification of the prospective nutrient

content claim or the prospective health

claim be submitted to FDA at least 120

days before a food bearing the claim

may be introduced into interstate

commerce. FDAMA and its

requirements are discussed in more

detail in a companion document

published elsewhere in this issue of the

Federal Register (see ‘‘Food Labeling:

Health Claims; Antioxidant Vitamins C

and E and the Risk in Adults of

Atherosclerosis, Coronary Heart Disease,

Certain Cancers, and Cataracts;’’

hereinafter referred to as ‘‘Health

Claims; Vitamins C and E’’). In

particular, aspects of the requirements

for an ‘‘authoritative statement’’ that are

relevant to this rulemaking and FDA’s

review process for notifications are

discussed in sections I.A and I.B,

respectively, of that document.

II. The Notification

Section 403(r)(2)(G) and (r)(3)(C) of

the act became effective on February 19,

1998. On February 23, 1998, the agency

received a notification from Weider

Nutrition International, Inc., containing

nine prospective claims that were

identified in the text of the notification

as health claims (Ref. 1). The

notification included statements that the

submitter described as authoritative

statements and a scientific literature

review for each claim. FDA has created

nine separate dockets, one for each of

the nine claims and is issuing a separate

interim final rule responding to each

claim.

This interim final rule addresses the

eighth claim in the notification. The

notification included two statements

that the petitioner identified as

authoritative statements on which the

following claim is based: ‘‘In adults,

zinc may increase the body’s ability to

fight infection and heal wounds.

Sources of zinc include whole grains,

fish, seafood, meat, poultry, eggs,

legumes, and dietary supplements.’’

The first sentence of this claim will be

discussed in greater detail in section III

of this document. The agency notes that

this claim describes the relationship

between zinc and two diseases and,

thus, in point of fact, reflects two

prospective health claims. The second

sentence, ‘‘Sources of zinc include

whole grains, fish, seafood, meat,

poultry, eggs, legumes, and dietary

supplements,’’ is not a health claim.

Given that the notification indicated

that it was intended to be a notification

for health claims, this statement was not

reviewed by FDA. The submitter did not

separately identify this statement as any

particular type of claim.

Nonetheless, as a point of

information, the agency wishes to

highlight that statements that

appropriately constitute nutrient

content claims are allowed on labels

and in the labeling of foods and dietary

supplements. Moreover, statements that

constitute dietary guidance are also

allowed provided the information is

truthful and not misleading as required

by sections 403(a) and 201(n) of the act

(21 U.S.C. 321(n)). These aspects of

nutrient content claims and dietary

guidance are discussed in more detail in

‘‘Health Claims; Vitamins C and E,’’

which is published elsewhere in this

issue of the Federal Register.

III. Basis for the Action

FDA has reviewed the notification

submitted in support of the prospective

claim: ‘‘In adults, zinc may increase the

body’s ability to fight infection and heal

wounds.’’ The agency has determined

that neither of the two statements

submitted as the basis for this claim

meets the requirements in section

403(r)(3)(C) of the act to be an

‘‘authoritative statement.’’ Because the

prospective claim is not based on

authoritative statements, it is not

appropriate for the claim to appear on

food labels and labeling. Consequently,

FDA is issuing this interim final rule to

prohibit the use of this claim. A

discussion of the basis for the agency’s

action on the notification follows.

First, FDA determined that the

components required by section

403(r)(3)(C) of the act were present in

the notification submitted to support

this claim. Second, FDA determined

that, as a threshold matter, the two

statements cited in support of the claim

may be attributable either to an

appropriate Federal scientific body or to

an employee or employees of such a

body.

The notification in support of the

claim that is the subject of this

document cites: (1) A report on

nutrition monitoring prepared for the

Department of Health and Human

Services (DHHS) and the U.S.

Department of Agriculture (USDA), and

(2) an electronic version provided on

the Internet of a quarterly report from

USDA’s Agricultural Research Service

(ARS). Thus, one statement in the

notification is attributable to USDA and

DHHS and is intended for use by

Federal agencies including the National

Institutes of Health (NIH), the Centers

for Disease Control and Prevention

(CDC), and USDA/ARS. The second

statement is attributable to USDA/ARS.

NIH and CDC are highlighted in the

statute as scientific bodies. FDA

believes that USDA/ARS is also a

scientific body of the U.S. Government

with official responsibility for public

health protection or research directly

relating to human nutrition for the

purposes of section 403(r)(2)(G) and

(r)(3)(C) of the act. Accordingly, the

statements provided in the notification

in support of the claim may be

attributable to appropriate Federal

scientific bodies or to their employees.

Finally, however, neither of the two

statements discussed in sections III.A

and III.B of this document was found to

be an authoritative statement.

A. Statement 1

Statement 1 reads: ‘‘Zinc is an

essential mineral in the diet and is a

component of many enzymes. As such,

it is involved in many metabolic

processes including wound healing,

immune function, growth and

maintenance of tissues.’’ The

notification identified Statement 1 as an

‘‘authoritative statement’’ for purposes

of making the claim that is the subject

of this rulemaking. The statement is

found in a discussion on minerals that

is contained in ‘‘Nutrition Monitoring in

the United States—An Update Report on

Nutrition Monitoring’’ that was

prepared for USDA and the Public

Health Service of DHHS by the Life

Sciences Research Office (LSRO) of the

Federation of American Societies for

Experimental Biology (FASEB) (DHHS

Publication No. (PHS) 89–1255,

September 1989, 71). The notification

provided a photocopy of selected pages

from the report.

The agency notes that the report was

prepared under a DHHS contract by

LSRO/FASEB, an organization that is

neither a Federal Government agency

nor affiliated with the National

Academy of Sciences. Contractual

activities involved in preparation of the

report were overseen by several Federal

agencies that participate in the National

Nutrition Monitoring System (NNMS).

The report provides an independent

expert panel’s review of the dietary and

nutritional status of the U.S. population,

as well as the factors that determine

status, based on information available

through the NNMS; the report is an

advisory document for the government

agencies. A disclaimer that appears on

the inside front cover of the report

(which was not included in the
34114 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

notification) states that, although the

report was printed and distributed as

part of a series of reports from the

NNMS, ‘‘the interpretations contained

in this report do not necessarily express

the views or policies of the U.S.

Government and its constituent

agencies’’ (Ref. 2). Additionally, as

noted in the foreword of the report (page

vii), representatives of participating

Federal Government agencies ‘‘reviewed

final drafts of the report for technical

accuracy and satisfaction of the scope of

work’’ (Ref. 2).

Given this disclaimer and the

statement from the foreword, the

component of the submitter’s

notification that provided ‘‘a concise

description of the basis upon which [the

submitter] relied for determining that

the requirements of [403(r)(3)(C)(i)] have

been satisfied’’ (as required by

403(r)(3)(C)(ii)(I) of the act) needed to

address why this statement was in fact

an authoritative statement. It did not.

The disclaimer indicates that Federal

Government agencies cannot be

considered to have ‘‘published’’ the

report in the sense that it represents

official policy of the agencies, as

discussed in section I.A.2 in ‘‘Health

Claims; Vitamins C and E,’’ which is

published elsewhere in this issue of the

Federal Register. The foreword of the

report indicates that it may involve a

deliberative review of the scientific

evidence about the dietary and

nutritional status of the U.S. population,

but that it does not involve a

deliberative review of the scientific

evidence about diet/disease

relationships. Further, the foreword

indicates that the Federal agencies did

not themselves conduct a deliberative

review of the scientific evidence

necessary for the statements in the

report to be ‘‘authoritative statements,’’

as described in section I.A.3 in ‘‘Health

Claims; Vitamins C and E,’’ which is

published elsewhere in this issue of the

Federal Register, but rather only a

review for technical accuracy of a final

draft of the report itself.

FDA concludes that the statement is

not an ‘‘authoritative statement’’

because it does not reflect the official

policy of an appropriate scientific body,

nor has an appropriate scientific body

conducted a deliberative review of the

scientific evidence.

B. Statement 2

Statement 2 reads: ‘‘Dietary zinc

shortages—a bigger problem in

developing countries than in the United

States—may be linked to depressed

growth in children, slower woundhealing and difficult births.’’ The

notification identified Statement 2 as an

‘‘authoritative statement’’ for purposes

of making the claim that is the subject

of this rulemaking. The statement is

found in Human Nutrition (quarterly

reports of selected research projects, 1st

quarter 1995) issued by the USDA’s ARS

and provided on the Internet (‘‘http://

www.ars.usda.gov/is/qtr/q195/

hn195.htm’’ accessed on 12/24/97).

Human Nutrition is a periodic

compilation of brief (one paragraph)

descriptions of ongoing research being

conducted within the various ARS

facilities. The subject statement

(submitted to the agency as a hardcopy

reprint from the Internet) appears in a

description of research entitled

‘‘Boosting a key amino acid in plants

could help people get more zinc in their

diets.’’ The paragraph describes the

nature and outcome of one ARS study

using rats and is attributed to William

House and Ross Welch of the United

States Plant, Soil and Nutrition

Laboratory, Ithaca, NY.

FDA asked USDA whether the

statement is an ‘‘authoritative

statement’’ under FDAMA. USDA

responded to FDA that the statement is

not an authoritative statement of USDA

because it was not based upon a

deliberative review of the scientific

evidence regarding a relationship

between the nutrient and the disease in

question. USDA explained that the ARS

quarterly reports describe progress on

individual projects without a

deliberative review of all relevant

scientific evidence (Ref. 3). Therefore,

FDA has concluded that the statement is

not an ‘‘authoritative statement’’ under

section 403(r)(3)(C) of the act because it

is not based on a deliberative review of

the scientific evidence.

In summary, FDA has concluded that

the notification does not include any

authoritative statement published by a

scientific body as required by section

403(r)(3)(C) of the act. Accordingly, the

subject claim relating to the relationship

between zinc and, in adults, the body’s

ability to fight infection and heal

wounds is not authorized under section

403(r)(3)(C) of the act and is, therefore,

prohibited. The agency notes that, at

any future time, a notification may be

submitted to the agency that bases such

a claim or claims on a statement that

meets the requirements of section

403(r)(3)(C) of the act. If there is no

authoritative statement that may serve

as a basis for such claims, an interested

person may petition the agency under

section 403(r)(4) of the act and 21 CFR

101.70 to authorize a health claim or

claims by regulation under section

403(r)(3)(B) of the act.

IV. Issuance of an Interim Final Rule,

Immediate Effective Date, and

Opportunity for Public Comment

For the reasons described in this

section of the document, FDA is issuing

this rule as an interim final rule,

effective immediately, with an

opportunity for public comment. New

section 403(r)(7)(B) of the act, added by

section 301 of FDAMA, provides that

FDA ‘‘may make proposed regulations

issued under [section 403(r)] effective

upon publication pending consideration

of public comment and publication of a

final regulation’’ if the agency

‘‘determines that such action is

necessary * * * to enable [FDA] to act

promptly to ban or modify a claim’’

under section 403(r) of the act. For

purposes of judicial review, ‘‘[s]uch

proposed regulations shall be deemed

final agency action.’’ The legislative

history indicates that the agency should

issue rules under this authority as

interim final rules (H. Conf. Rept. 105–

399, at 98 (1997)).

As described in section III of this

document, FDA has determined that the

statements submitted in support of the

prospective health claim do not meet

the requirements for authoritative

statements in section 403(r)(3)(C) of the

act. FDA has determined that it is

necessary to act promptly to prohibit the

claim’s use under section 403(r)(3)(C) of

the act, and accordingly, is issuing this

interim final rule to ban its use under

section 403(r)(3)(C).

FDA invites public comment on this

interim final rule. The agency will

consider modifications to this interim

final rule based on comments made

during the comment period. Interested

persons may, on or before September 8,

1998, submit to the Dockets

Management Branch (address above)

written comments regarding this interim

final rule. Comments must be received

by that date. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

V. Environmental Impact

The agency has determined under 21

CFR 25.30(k) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 34115

VI. Analysis of Economic Impacts

A. Benefit-Cost Analysis

FDA has examined the impacts of this

interim final rule under Executive Order

12866. Executive Order 12866 directs

Federal agencies to assess the costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). According to

Executive Order 12866, a regulatory

action is ‘‘significant’’ if it meets any

one of a number of specified conditions,

including having an annual effect on the

economy of $100 million; adversely

affecting in a material way a sector of

the economy, competition, or jobs; or if

it raises novel legal or policy issues.

FDA finds that this interim final rule is

not a significant regulatory action as

defined by Executive Order 12866. In

addition, it has been determined that

this interim final rule is not a major rule

for the purpose of congressional review.

If in the future FDA authorizes health

claims relating to the relationship

between zinc and, in adults, the body’s

ability to fight infection and heal

wounds after finding that there is

significant scientific agreement about

these relationships, the cost to

consumers of prohibiting this claim at

this time would be the cost of having

kept, in the interim, information from

appearing in food labeling that would

ultimately be shown to be scientifically

valid, truthful, and not misleading. At

this time, the benefit to consumers of

prohibiting this claim is that a claim

that has not been shown to be

scientifically valid will not appear in

food labeling. Accordingly, consumers

will be able generally to have

confidence when they read food

labeling that any diet/disease

relationship information in that labeling

has been shown to be scientifically

valid.

A health claim relating to the

relationship between zinc and, in

adults, the body’s ability to fight

infection and heal wounds has not been

authorized under existing regulations.

The prohibition of this claim in this

interim final rule results in no

regulatory changes for firms, and

therefore no costs to firms are

attributable to this interim final rule.

B. Small Entity Analysis

FDA has examined the impacts of this

interim final rule under the Regulatory

Flexibility Act. The Regulatory

Flexibility Act (5 U.S.C. 601–612)

requires Federal agencies to consider

alternatives that would minimize the

economic impact of their regulations on

small businesses and other small

entities. In compliance with the

Regulatory Flexibility Act, FDA finds

that this interim final rule will not have

a significant impact on a substantial

number of small entities.

A health claim relating to the

relationship between zinc and, in

adults, the body’s ability to fight

infection and heal wounds has not been

authorized under existing regulations.

The prohibition of this claim in this

interim final rule results in no

regulatory changes for firms, and

therefore this rule will not result in a

significant increase in costs to any small

entity. Therefore, this rule will not have

a significant economic impact on a

substantial number of small entities.

Accordingly, under the Regulatory

Flexibility Act (5 U.S.C. 601–612), the

agency certifies that this interim final

rule will not have a significant

economic impact on a substantial

number of small entities.

C. Unfunded Mandates Reform Act of

1995

FDA has examined the impacts of this

interim final rule under the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). This interim final rule

does not trigger the requirement for a

written statement under section 202(a)

of UMRA because it does not impose a

mandate that results in an expenditure

of $100 million or more by State, local,

and tribal governments in the aggregate,

or by the private sector, in any 1 year.

VII. The Paperwork Reduction Act of

1995

This interim final rule contains no

collections of information. Therefore,

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520) is not required.

VIII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Notification to Donna E. Shalala, DHHS,

from Jonathan W. Emord et al., Emord &

Associates, P.C., Counsel for Weider

Nutrition International, Inc., February 23,

1998.

2. LSRO, FASEB, ‘‘Nutrition Monitoring in

the United States—An Update Report on

Nutrition Monitoring,’’ prepared for USDA

and DHHS, DHHS Pub. No. (PHS) 89–1255,

PHS, DHHS, U.S. Government Printing

Office, Washington, DC, inside front cover

and pp. iii–vii, September, 1989.

3. Letter to Christine Lewis, CFSAN, FDA,

from Eileen Kennedy, USDA, May 7, 1998.

Dated: June 16, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–16461 Filed 6–19–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98N–0420]

Food Labeling: Health Claims; Vitamin

K and Promotion of Proper Blood

Clotting and Improvement in Bone

Health in Adults

AGENCY: Food and Drug Administration,

HHS.

ACTION: Interim final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

interim final rule to prohibit the use on

foods of a health claim relating to

relationships between vitamin K and the

promotion of proper blood clotting and

improvement in bone health in adults.

This interim final rule is in response to

a notification of a health claim

submitted under section 303 of the FDA

Modernization Act of 1997 (FDAMA).

FDA has reviewed the notification, and,

in conformity with the requirements of

FDAMA, the agency is prohibiting the

claim as a health claim because the

claim does not characterize the

relationship of the nutrient vitamin K to

a disease or health-related condition, as

required by section 303 of FDAMA;

therefore, section 303 of FDAMA does

not authorize use of this claim as a

health claim. Although the claim is not

a health claim, it may be the type of

claim permissible as a structure/

function claim. As provided for in

section 301 of FDAMA, this rule is

effective immediately upon publication.

DATES: The interim final rule is effective

June 22, 1998; comments by September

8, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Christine J. Lewis, Center for Food

Safety and Applied Nutrition (HFS–

451), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4168.