Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Notices 4839

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1598]

Draft Guidance for Industry: Voluntary

Labeling Indicating Whether Foods

Have or Have Not Been Developed

Using Bioengineering; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA (we)) is

announcing the availability of a draft

guidance for industry entitled

‘‘Voluntary Labeling Indicating Whether

Foods Have or Have Not Been

Developed Using Bioengineering.’’ FDA

developed this draft guidance to assist

manufacturers, who wish to voluntarily

label their foods (human and animal) as

being made with or without

bioengineering or the use of

bioengineered ingredients, to ensure

that labeling is truthful and not

misleading. FDA is taking this action in

response to requests from food

manufacturers and as part of the Clinton

administration’s initiatives to strengthen

science-based regulation of

bioengineered foods and consumer

access to information.

DATES: Submit written comments

concerning the draft guidance to ensure

adequate consideration in the

preparation of a revised guidance, if

warranted, by March 19, 2001. However,

you may submit written comments at

any time. Submit written comments

concerning the collection of information

by March 19, 2001.

ADDRESSES: Submit written comments

on the draft guidance and the collection

of information to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Identify the comments with the docket

number found in brackets in the

heading of this document. Submit

written requests for single copies of the

draft guidance entitled ‘‘Draft Guidance

for Industry: Voluntary Labeling

Indicating Whether Foods Have or Have

Not Been Developed Using

Bioengineering’’ to the Office of

Nutritional Products, Labeling, and

Dietary Supplements (HFS–800), Center

for Food Safety and Applied Nutrition,

Food and Drug Administration, 200 C

St. SW., Washington, DC 20204. Send

one self-addressed adhesive label to

assist that office in processing your

request, or include a fax number to

which the draft guidance may be sent.

Alternatively, you may request a copy of

the draft guidance by calling 202–205–

4561, or you may fax your request to

202–205–4594. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Regarding human food issues:

Catalina Ferre-Hockensmith, Center

for Food Safety and Applied

Nutrition (HFS–822), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–

4168.

Regarding animal feed issues:

William D. Price, Center for

Veterinary Medicine (HFV–200),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–6652.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 29,

1992 (57 FR 22984), FDA published its

‘‘Statement of Policy: Foods Derived

from New Plant Varieties’’ (the 1992

policy). The 1992 policy applies to

foods (human and animal) developed

from new plant varieties, including

varieties that are developed using

recombinant deoxyribonucleic acid

(rDNA) technology, which is often

referred to as ‘‘genetic engineering,’’

‘‘biotechnology,’’ or ‘‘bioengineering.’’

The 1992 policy provides guidance to

industry on scientific and regulatory

issues related to bioengineered foods

and solicited written comments from

interested persons. It includes guidance

on questions to be answered by

developers of foods from new plant

varieties to ensure that the new

products are safe and comply with

applicable legal requirements.

In the 1992 policy, we also address

the labeling of foods derived from new

plant varieties, including plants

developed by bioengineering. The 1992

policy does not establish special

labeling requirements for bioengineered

foods as a class of foods. The 1992

policy states that we have no basis for

concluding that bioengeered foods differ

from other foods in any meaningful or

uniform way, or that, as a class, foods

developed by the new techniques

present any different or greater safety

concern than foods developed by

traditional plant breeding.

Although we do not require special

labeling for bioengineered foods, as a

class of foods, in the 1992 policy we

advised that labeling requirements that

apply to foods in general also apply to

foods produced using biotechnology.

Section 403(i) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

343(i)) requires that each food bear a

common or usual name or, in the

absence of such a name, an

appropriately descriptive term. In

addition, under section 201(n) of the act

(21 U.S.C. 321(n)), the labeling of food

must reveal all facts that are material in

light of representations made in the

labeling or in light of consequences that

may result from the use of the foods.

Thus:

• If a bioengineered food is

significantly different from its

traditional counterpart, such that the

common or usual name no longer

adequately describes the new food, the

name must be changed to describe the

difference.

• If an issue exists for the food or a

constituent of the food regarding how

the food is used or consequences of its

use, a statement must be made on the

labeling to describe the issue.

• If a bioengineered food has a

significantly different nutritional

property, its labeling must reflect the

difference.

• If a new food includes an allergen

that consumers would not expect to be

present based on the name of the food,

the presence of that allergen must be

disclosed in the labeling.

In the Federal Register of April 28,

1993 (58 FR 25837), we requested data

and information (the 1993 information

request) on certain labeling issues that

had arisen from the labeling guidance in

the 1992 policy. In 1999, we held three

public meetings (64 FR 57470, October

25, 1999). The purpose of those

meetings was for us to share our current

approach and experience over the

previous 5 years regarding

bioengineered foods, to solicit views on

whether our policies should be

modified, and to gather information to

be used to assess the most appropriate

means of providing information to the

public about bioengineered products in

the food supply. We received more than

50,000 written comments about our

policy regarding safety and labeling of

bioengineered foods. The theme related

to labeling in those comments and the

testimony at the meetings was that there

are very strongly held but divergent

views as to whether bioengineered foods

should be required to bear special

labeling. However, there was general

agreement that providing more

information to consumers about

bioengineered foods would be useful. A

number of comments supported the

need for guidance from FDA regarding

appropriate ways that industry could

voluntarily provide information on a

food label about bioengineering.

4840 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Notices

We have reviewed information in the

comments received in response to the

1992 policy and the 1993 information

request as well as the comments from

the meetings held in 1999. Most of the

comments that addressed labeling

requested mandatory disclosure of the

fact that the food or its ingredients was

bioengineered or was produced from

bioengineered food. However, these

comments did not provide data or other

information regarding consequences to

consumers from eating the foods or any

other basis for us to find under section

201(n) of the act that such a disclosure

was a material fact. Many of the

comments expressed concern about

possible long-term consequences from

consuming bioengineered foods, but

they did not contend that any of the

bioengineered foods already on the

market have adverse health effects. The

comments were mainly expressions of

concern about the unknown. We are still

not aware of any data or other

information that would form a basis for

concluding that the fact that a food or

its ingredients was produced using

bioengineering is a material fact that

must be disclosed under sections 403(a)

and 201(n) of the act. We are, therefore,

reaffirming our decision to not require

special labeling of all bioengineered

foods.

We are providing guidance to assist

manufacturers who wish to label their

foods voluntarily as being made with or

without the use of bioengineered

ingredients. While the use of

bioengineering is not a material fact,

many consumers are interested in the

information, and some manufacturers

may want to respond to this consumer

desire. We developed this guidance

using information from the comments

and from focus groups, as well as other

resources. The guidance is intended to

help manufacturers ensure that their

labeling is truthful and not misleading.

In addition, because the act defines food

as articles used for food or drink for

man or other animals, this guidance

applies to animal feeds as well as to

human foods.

The guidance addresses the use of

statements in the labeling of foods that

are bioengineered or contain

bioengineered ingredients. It is intended

to provide guidance on how a

manufacturer may make statements in

the labeling about bioengineered foods

and ingredients, without such

statements being false or misleading.

The guidance also addresses the use

of statements in the labeling that

indicate that the food, or its ingredients,

was not bioengineered. The agency is

soliciting comments on the entire

guidance document, but it is

particularly interested in comments on

how the draft guidance deals with

statements like ‘‘GMO free,’’ ‘‘GM free,’’

‘‘biotech free,’’ and ‘‘no genetically

engineered materials.’’ For example, we

are seeking comment on whether, and

how, statements like ‘‘GM free’’ or ‘‘no

genetically engineered material’’ can be

made without being false or misleading.

In the guidance document, FDA advises

that the term ‘‘free’’ may be difficult to

use without being false or misleading. If

it implies ‘‘zero,’’ it may be very

difficult to substantiate. The

adventitious presence of bioengineered

material may make a ‘‘zero’’ claim

inaccurate. Further, these terms would

be misleading if they imply that the

food is superior because the food is not

bioengineered. We have concluded that

the use, or absence of use, of

bioengineering in the production of a

food is not a fact that is material either

with respect to consequences resulting

from the use of the food or due to

representations on the labeling.

We suggest in the guidance that terms

like ‘‘GM free’’ and ‘‘biotech free’’ either

not be used in bioengineering labeling

statements or be in a context that makes

clear that a zero level of bioengineered

material is not implied. We recognize

that the terms are popular among those

manufacturers who have already made

label statements that a food was not

bioengineered. FDA requests comments

on whether statements like ‘‘GM free,’’

‘‘biotech free,’’ and ‘‘no genetically

engineered materials’’ can be made

without being false or misleading, and,

if so, how. Does such a statement imply

zero content of bioengineered material?

If so, would a clarifying statement help

the consumer to understand that there

may be some low level of bioengineered

material present? Should substantiation

of no detectable bioengineered material

be required in the absence of a clarifying

statement? Does ‘‘biotech free’’ or

another similar term imply that the

labeled food is superior to foods that are

not so labeled? If so, would a clarifying

statement, for example, a statement that

the absence of the use of bioengineering

does not make the food superior to food

not so labeled or to a bioengineered food

or ingredient, clarify the term

adequately? Would such a clarifying

statement be needed in all instances or

are there some uses of ‘‘GM free’’ and

similar terms that would not imply that

the labeled food is superior, and why?

We specifically request comment on

these as well as any other aspects of

how to avoid false or misleading

statements in the labeling about the

absence of use of bioengineering in the

production of a food or its ingredients.

This Level 1 draft guidance represents

our current thinking on the voluntary

labeling indicating whether foods have

or have not been developed using

bioengineering. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such an approach satisfies the

requirements of applicable statutes, and

regulations. The draft guidance is being

distributed for comment purposes in

accordance with FDA’s good guidance

practices (65 FR 56468, September 19,

2000).

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act

of 1995 (the PRA) (44 U.S.C. 3501–

3520), Federal agencies must obtain

approval from the Office of Management

and Budget (OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Suggested Documentation for

Substantiating Whether Foods Have or

Have Not Been Developed Using

Bioengineering

Description: The 1992 policy stated

that the method of development of a

new plant variety, including plants

developed using bioengineering, is not

information that is material under

section 201(n) of the act and, therefore,

would not be required in the labeling of

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Notices 4841

food. This conclusion is consistent with

our historic interpretation of section

201(n) of the act, in that the method of

plant breeding is not required to be

disclosed in labeling. In the 1993

information request, we requested

additional information on labeling

issues that had risen from our 1992

policy. Subsequently, in 1999, we held

three public meetings to get public

input on our existing policy with regard

to its premarket review of foods

produced through biotechnology and

the labeling of such products. In

response to comments that we received

on our 1992 policy, the 1993

information request, and the public

meetings, we decided to develop

guidance for voluntary labeling

indicating whether foods have or have

not been developed using

bioengineering. This guidance will

assist manufacturers in labeling foods

that have or have not been developed

using bioengineering so that the labeling

statement is truthful, not misleading,

and scientifically valid. The information

that the manufacturers will collect is

documentation of handling practices so

that they can truthfully label their

products to indicate, if they so choose,

whether the food has or has not been

developed using bioengineering.

In general, FDA anticipates that

manufacturers that claim that a product

is not developed using bioengineered

material would substantiate the claim. If

validated testing is not available to

ensure the absence of bioengineered

material for a specific food, we suggest

that manufacturers document handling

practices to substantiate a claim that a

food was not developed using

bioengineering, rather than using a

‘‘free’’ claim. Thus, to substantiate

handling practices, the manufacturers

would have to document the source of

such foods. Examples of documentation

that we anticipate will demonstrate

handling practices and procedures

about how the food was processed are

recordkeeping, certifications or

affidavits from farmers, processors, and

others in the food production and

distribution chain. We are neither

suggesting that firms maintain a certain

set list of documents nor are we

suggesting that anything less or different

would likely be considered

unacceptable. Rather, we are leaving it

to each firm’s discretion to maintain

appropriate documentation to

demonstrate that the food was produced

using traditional methods.

Description of Respondents:

Manufacturers of foods that were and

were not produced using

bioengineering.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Operating and

Maintenance Costs Total Hours

893 21 18,753 1 $1,781,400 18,753

1There are no capital costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

No. of Recordkeepers

Annual

Frequency per

Recordkeeper

Total Annual

Records

Hours per

Recordkeeper

Operating and

Maintenance

Costs

Total Hours

68 26 1,768 1 $53,040 1,768

1There are no capital costs associated with this collection of information.

FDA estimates that almost all of the

organic producers and manufacturers

who have issued statements that they

will not use bioengineered ingredients

will choose to label, and therefore, will

incur the reporting burden. We

determined the estimates for the annual

reporting burden by using the

approximately 18,753 products (16,985

organic products and 1,768 non-organic

products) from producers who may not

use bioengineered ingredients in their

products. These manufacturers include

producers who market to a niche of

consumers who choose not to use

products with bioengeered ingredients

and manufacturers who have stated that

they do not use bioengineered

ingredients in their products. We

estimated that the numbers of firms that

will choose to label is 893 (825 firms for

organic products and 68 for non-organic

products). We estimated that the

manufacturers of these products would

choose to state on their label and in

their labeling that those products were

not developed using bioengineering.

Such labeling would increase their

paperwork burden. The estimates on the

annual reporting burden (table 1 of this

document) are based on agency

knowledge of, and experience with,

food labeling. The 18,753 product

estimate may be too low if FDA has

been unable to identify all producers

that could use non-bioengineering labels

or if FDA’s labeling guidance

encourages producers who have not

issued bioengineering statements to now

use such statements on the label. On the

other hand, this may be an overestimate

if some producers, who have been

making statements indicating that they

will try to use foods that were not

developed using bioengineering, choose

not to label their products.

We believe that the burden associated

with the voluntary labeling of foods that

have not been developed using

bioengineering would be a one-time

burden for the small number of firms

that would decide, voluntarily, to add

this additional information to the labels

for their products, separate from any

other label changes for their products.

We estimate that at least 90 percent of

firms would coordinate the addition of

the statement on the label that their

products were not developed using

bioengineering with other changes in

their labels, in which case the voluntary

cost of transmitting the information to

consumers in labeling would be

included almost entirely in the cost of

other voluntary or required labeling

changes. The incremental cost for these

803 firms (893 x 90 percent) would be

approximately $50 per label for 16,878

labels, or $843,900 total. For the

remaining 90 firms that would not

coordinate changes with other labeling

changes, we estimate that the cost

would be approximately $500 per label

for 1,875 labels, or $937,500 total. The

estimated total operating and

4842 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Notices

maintenance costs in table 1 of this

document are, therefore, $1,781,400.

When determining the annual

recordkeeping burden (table 2 of this

document), we estimated that the

number of firms that would maintain

records to substantiate labeling that

their products were not developed using

bioengineering is the same as the

number of respondents with the

reporting burden minus the number of

firms marketing organic products (i.e.,

68). We did not include products that

are labeled ‘‘organic’’ in the estimated

annual recordkeeeping burden because

according to a proposal in the Federal

Register of March 13, 2000 (65 FR

13512), issued by the Agriculture

Marketing Service of the U.S.

Department of Agriculture, a food

labeled as ‘‘organic’’ would not be

permitted to contain bioengineered

materials. Therefore, the 16,985 organic

products available today would be able

to bear a voluntary labeling statement

that the food was not developed using

bioengineering. Thus, there is no

additional paperwork burden to

substantiate a claim that a product is not

developed using bioengineering for

these products. Because most of the

non-organic products whose producers

have stated they will not use

bioengineered ingredients are made by

large firms for whom the verification

process is not likely to impose a

significant burden relative to the size of

their operation, we assume that the

paperwork processing time associated

with testing or source verification for

these products is approximately 1 hour

for a total of 1,768 hours per year.

Therefore, FDA estimated that the total

recordkeeping burden would be 1,768

hours per year. Based on our

experience, we have estimated that the

overhead and maintenance cost are $30

per hour. The estimated total operating

and maintenance cost in table 2 of this

document are, therefore, $53,040 total.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance by March 19, 2001, to ensure

adequate consideration in the

preparation of a revised guidance, if

warranted. However, interested persons

may submit written comments at any

time. 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. Submit to the Dockets

Management Branch written comments

concerning this collection of

information by March 19, 2001. The

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

IV. Electronic Access

An electronic version of the draft

guidance also is available on the

Internet at http://www.cfsan.fda.gov/

dms/.

Dated: November 15, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–1047 Filed 1–17–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Organ Procurement

and Transplantation Network (42 CFR

Part 121, OMB No. 0915–0184):

Extension

The operation of the Organ

Procurement and Transplantation

Network (OPTN) necessitates certain

recordkeeping and reporting

requirements in order to perform the

functions related to organ

transplantation under contract to HHS.

This is a request for an extension of the

current recordkeeping and reporting

requirements associated with the OPTN.

These data will be used by HRSA in

monitoring the contracts for the OPTN

and the Scientific Registry and in

carrying out other statutory

responsibilities. Information is needed

to match donor organs with recipients,

to monitor compliance of member

organizations with OPTN rules and

requirements, and to ensure that all

qualified entities are accepted for

membership in the OPTN.

The estimated annual response

burden is as follows:

ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN

Section and activity Number of

respondents

Responses

per

respondent

Total

responses

Hours

per response

Total

burden hours

121.3(b)(2)—OPTN membership and application requirements for OPOs, hospitals, histocompatibility laboratories ................................................................................. 30 1 30 40 1,200

121.6(c)—Submitting criteria for organ acceptance ............ 900 1 900 0.1 90

121.6(c)—Sending criteria to OPOs .................................... 900 1 900 0.1 90

121.7(b)(4)—Reasons for Refusal ....................................... 900 0.5 34,200 0.1 3,420

121.7(e)—Transplant to prevent organ wastage ................. 900 0.5 420 0.1 42

121.9(b)—Designated Transplant Program Requirements 10 1 10 2 20